BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
U.S. Approvals, 2002-Early 2021

This is a list of new full FDA approvals for biopharmaceutical products (unless otherwise noted).

[Caution, approvals may not mean what you presume they do! Granting of full approval (BLA/NDA) does not always mean that the product or its active agent is new or even that manufacture or formulation has been significantly modified. The new full approval can just mean that a new full application (with something new or changed) was granted. Full approvals are sometimes granted for already-marketed products for new indications and manufacturing-related changes that are usually handled by supplemental approvals. To a lesser extent the converse also occurs, with clearly new and distinct/different products granted supplemental approvals.
For further information about basic definitions, such as "What is a biopharmaceutical?," visit www.biopharmacopeia.com. Note, diagnostics approved as biologics, non-recombinant allergenic extracts, and synthetic peptides and polynucleotides are not considered biopharmaceuticals here.

2021

SARS-CoV-2 Ad26 vector vaccine, rDNA [Jemperli - dostarlimab-gxly] accelerated ƒapproval granted to GlaxoSmithKline (GSK) on April 23 for prevention of endometrial cancer

SARS-CoV-2 Ad26 vector vaccine, rDNA approval granted (as an emergency use authorization) to Janssen Biotech/Johnson & Johnson (J&J) on Feb. 27 for prevention of Covid-19 disease

SARS-CoV-2 mAbs, rDNA [bamlanivimab and etesevimab] approval granted for this 2-antibody 'cocktail' (only approved as combination) to Eli Lilly & Co. on Feb. 10 for treatment of Covid-19 infection

CD19 T-cells gene/cellular therapy, rDNA [Breyanzi - lisocabtagene maraleucel; liso-cel; using lentivirus gene therapy vector] approval granted to this gene therapy vector-modified autologous cellular therapy Bristol Myers Squibb on Feb. 3 for treatment of late-stage lymphoma

glucagon, synthetic [Riabni - rituximab-arrx] generic drug approval granted to Amgen on Jan. 11 as a biosimilar version of Rituxan for treatment of polyangiitis (GPA) and microscopic polyangiitis (MPA; the two most common subtypes of ANCA-associated vasculitis), non-Hodgkin's lymphoma and chronic lymphocytic leukemia

2020

glucagon, synthetic [Glucagon for Injection Emergency Kit] synthetic, not a biopharmaceutical (but could be consided to formely be one); ANDA (supplemental) generic drug approval granted to Amphastar Pharmaceuticals, Inc. on Dec. 29, 2020 for treatment of severe hypoglycemia (and also as a diagnostic aid), with this synthetic glucagon "determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly's Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin." [An outlier, a biosimilar-equivalent supplemental NDA approval granted to clearly a new drug substance and product, here a synthetic version of a recombinant reference product. This could also be considered to be an authorized biosimilar generic drug approval.]

Ebola virus mAb, rDNA [Ebanga - ansuvimab-zykl] Emergency Use Authorization (EUA; not full appproval) granted to Ridgeback Biotherapeutics, LP on Dec. 21, 2020 for prevention of Zaire Ebolavirus infection

SARS-CoV-2 spike protein mRNA [Moderna COVID-19 Vaccine] Emergency Use Authorization (EUA; not full appproval) granted to ModernaTX, Inc. (Moderna) on Dec. 18, 2020 for prevention of COVID-19 disease due to SARS-CoV-2 infection

CD20 mAb, rDNA [Riabni - rituximab-arrx, recombinant] approval granted to Amgen on Dec. 17, 2020 as a biosimilar of Rituxan and its approved indications

Her/neu mAb, rDNA [Margenza - margetuximab-cmkb, recombinant] approval granted to Macrogenics on Dec. 16, 2020 for treatment of HER2-positive breast cancer

SARS-CoV-2 spike protein, rDNA [Pfizer-BioNTech COVID-19 Vaccine] Emergency Use Authorization (EUA; not full appproval) granted to Pfizer (partnered with BioNTech) on Dec. 11, 2020 for prevention of COVID-19 disease due to SARS-CoV-2 infection

GD2 mAb, rDNA [Danyelza - naxitamab-gpgk; glycolipid disialoganglioside (GD2) monoclonal antibody, recombinant] accelerated approval granted to Y-mAbs Therapeutics, Inc. on Nov. 25, 2020 for treatment of neuroblastoma in the bone or bone marrow

hydroxyacid oxidase RNAi, rDNA [Oxlumo - lumasiran; HA01 RNAi; glycolate oxidase RNAi; HAO1 mRNA-targeting siRNA-amino sugar N-acetylgalactosamine conjugate] approval granted to Alnylam on Nov. 24, 2020 for treatment of primary hyperoxaluria type 1 [Note, presume manufactured using recombinant methods vs. chemical synthesis]

SARS-CoV-2 spike protein mAbs, rDNA [casirivimab and imdevimab] Emergency Use Authorization (EUA; not full appproval) granted to Regeneron Pharmaceuticals Inc. on Nov. 21, 2020 for treatment of mild-to-moderate COVID-19

SARS-CoV-2 spike protein mAb, rDNA [bamlanivimab - LY-CoV555] Emergency Use Authorization (EUA; not full appproval) granted to Eli Lilly and AbCellera on Nov. 9, 2020 for treatment of mild-to-moderate COVID-19

Ebola virus mAb, rDNA [Inmazeb - odesivimab-ebgn; atoltivimab; maftivimab] granted to Regeneron Pharmaceuticals on Oct. 14, 2020 for treatment of Zaire ebolavirus (Ebola virus) infection

somatropin-albumin binding fusion, rDNA [Sogroya - somapacitan-beco] granted to Novo Nordisk on Aug. 28, 2020 for treatment of growth hormone deficiency

IL-6r mAb mAb, rDNA [Enspryng - satralizumab-mwge; AQP4 mAb] granted to Genentech/Hoffmann-La Roche, on Aug. 17, 2020 for treatment of neuromyelitis optica spectrum disorder (NMOSD)

DMD exon, RNAi [Viltepso - viltolarsen; Duchenne muscular dystrophy (DMD) gene antisense oligonucleotide] accelerated approval granted to NS Pharma, on Aug. 12, 2020 for treatment of Duchenne muscular dystrophy (DMD) [Note, presumed synthetic and not a biopharmaceutical/biologic]

BMCMA mAb-cytotoxin, rDNA [Blenrep - belantamab mafodotin-blmf] accelerated approval granted for this antibody-drug conjugate (ADC) to GlaxoSmithKline (GSK) on Aug. 5, 2020 for treatment of multiple myeloma

CD19 mAb mAb, rDNA [Monjuvi - tafasitamab-cxix; CD19 monoclonal antibody, recombinant] accelerated approval granted to Morphosys on July, 31, 2020 for treatment of diffuse large B-cell lymphoma (DLBCL)

T-cell therapy, autologous, rDNA [Tecartus - brexucabtagene autoleucel; KTE-X19; a CAR-T cell/gene therapy] accelerated approval granted to Kite Pharma (Gilead) on July 24, 2020 for treatment of mantle cell lymphoma (MCL); Note, reported as full BLA, but no random suffix appended to the FDA proper name.

TNF mAb mAb, rDNA [Hulio - adalimumab-fkjp; FKB327] granted to Mylan and Fujifilm Kyowa Kirin Biologics Co., Ltd. on July 9, 2020 as a biosimilar of Humira for treatment of Humira's approved indictions (rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis)

collagenase [Qwo - collagenase Clostridium histolyticum-aaes] NDA (not BLA) granted to Endo International plc on July 6, 2020, for treatment of moderate to severe cellulite in the buttocks of adult women

Her mAbs + hyaluronidase, rDNA [Phesgo - pertuzumab, trastuzumab and hyaluronidase-zzxfl; a fixed combination of Perjeta/pertuzumab, Herceptin/trastuzumab and hyaluronidase-zzxf] granted to Genentech/Roche on June 21, 2020, for treatment of early HER2-positive breast cancer

insulin lispro, rDNA [Lyumjev - insulin lispro-aabc] granted to Eli Lilly & Co. on June 18, 2020 for treatment of type 1 and type 2 diabetes [Note, a biobetter version of Humalog also from Lilly]

insulin glargine, rDNA [Semglee - inebilizumab-cdon] 505(b)(2) generic drug NDA approval granted to Biocon on June 11, 2020, essentially as a (biosimilar of Lantus, for treatment of diabetes

aquaporin-4 mAb, rDNA [Uplinza - inebilizumab-cdon] approval granted on June 11, 2020 to Viela Bio for treatment of neuromyelitis optica spectrum disorder (NMOSD)

filgrastim, PEG-, rDNA [Nyvepria - pegfilgrastim-apgf; PF529; HSP-130; PF-06881894] approval granted on June 11, 2020 as a biosimilar of of Nuelasta to Pfizer for treatment of neutropenia

Meningococcal vaccine A/C/Y/W [MenQuadfi - Meningococcal (Groups A, C, Y, W) Conjugate Vaccine] granted on April 23, 2020 to Sanofi-Aventis U.S. LLC for prevention of invasive meningococcal disease

Trop-2 mAb-SN38, rDNA [Trodelvy - sacituzumab govitecan-hziy] antibody-drug conjugate (ADC) approval granted on Apri 22, 2020 to Immunomedics (now Gilead) for treatment of metastatic triple-negative breast cancer

Factor VIIa, rDNA [Sevenfact - Coagulation Factor VIIa (Recombinant)] granted on April 2, 2020 to Laboratoire Francais du Fractionnement et des Biotechnologies SA (LFB S.A.) for treatment of hemophilia A or B with inhibitors

CD38 mAb, rDNA [Sarclisa - isatuximab-irfc; SAR650984] granted on March 2, 2020 to Sanofi-Aventis U.S. LLC for treatment of multiple myeloma

Influenza vaccine, MF-59 [Fluad Quadrivalent, Seqirus - quadravalent influenza vaccine with MF-59 adjuvant] granted on Feb. 25, 2020 to Seqirus for prevention of seasonal influenza

CGRP mAb, rDNA - [eptinezumab-jjmr - Vyepti; calcitonin gene-related peptide ligand monoclonal antibody] granted on Feb. 21, 2020 to Lundbeck for treatment of migraine

Influenza (H5N1) vaccine [Audenz - Influenza A (H5N1) Monovalent Vaccine, Adjuvanted] granted on Jan. 31, 2020 to Seqirus Inc. for prevention of influenza A virus H5N1 infection

IGF-1R mAb, rDNA [Tepezza - teprotumumab-trbw; RG-1507; insulin-like growth factor-1 receptor inhibitor monoclonal antibody] granted on Feb. 20, 2020 to Horizon Therapeutics Ireland DAC for treatment of thyroid eye disease

2019 [Note, 2 below are considered drugs, not biopharmaceuticals]

Immune Globulin s.c. [Cutaquig - Immune Globulin Subcutaneous (Human)] granted on Dec. 26, 2019 to OCTAPHARMA Pharmazeutika for treatment of primary humoral immunodeficiency

Calcitonin, rDNA [Ubrelvy - ubrogepant] granted on Dec. 23, 2019 to Allergan USA, Inc. (being acquired by AbbVie) for treatment of migraine [apparently, a 505[b][2] generic drug approval, considered to be equivalent to a biosimilar approval]

Her-2 mAb--deruxtecan conjugate, rDNA [Enhertu - fam-trastuzumab deruxtecan-nxki] approval for this antibody-drug conjugate (ADC) granted on Dec. 20, 2019 to AstraZeneca and Daiichi Sankyo Co. Ltd. for treatment of breast cancer

Ebola vaccine [Ervebo - Ebola Zaire Vaccine, Live; V920] approval granted on 12/19/2019 to Merck & Co. for prevention of Ebola disease (caused by Zaire ebolavirus)

Nectin-4 mAb--monomethyl auristatin E (MMAE), rDNA [enfortumab vedotin-ejfv - Padcev] approval granted to this antibody-drug conjugate (ADC) on 12/18/2019 to Seattle Genetics Inc. and Astellas Pharm Inc. for treatment of urothelial cancer (bladder cancer)

dystrophin pre-mRNA antisense oligonucleotide [Viondys 53 - golodirsen] approval granted on Dec. 12, 2019 to Sarepta Therapeutics, Inc. for treatment of Duchenne muscular dystrophy [Note, synthetic, not considered a biopharmaceutical]

TNF mAb, rDNA [Avsola - infliximab-axxq; ABP 710] approval granted on 12/6/2019 to Amgen as a biosimilar version of Remicade for treatment of autoimmune disorders (Remicade's approved indications

GalNAc-RNAi conjugate [Givlaari - givosiran; ALN-AS1; liver-targeted ligand N-acetylgalactosamine (GalNAc) conjugated to small-interfering RNAs (siRNAs); ESC-GalNAc-siRNA conjugate ALN-AS1] approval granted on 11/15/2019 to Novartis (acquired from Selexis) to reduce the frequency of vaso-occlusive crises (VOCs) for treatment of acute hepatic porphyria [Note, synthetic, not considered a biopharmaceutical]

P-selectin mAb, rDNA [crizanlizumab-tmca - Adakveo] approval granted on 11/15/2019 to Novartis (acquired from Selexis) to reduce the frequency of vaso-occlusive crises (VOCs) as part of treatment of Sickle cell disease

TNF mAb, rDNA [adalimumab-afzb - Abrilada] approval granted on 11/8/2019 to Pfizer as a biosimilar of Humira for treatment of treatment of certain patients with Humira's diverse indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

activin receptor-IgG1 Fc fusion protein, rDNA [luspatercept-aamt - Reblozyl] approval granted on 11/8/2019 to Celgene (merging into Bristol-Myers Squibb/BMS) for treatment of anemia in adults with beta thalassemia.

G-CSF, PEG-, rDNA [pegfilgrastim-bmez - Ziextenzo] approval granted on 11/4/2019 to Sandoz/Novartis as a biosimilar version of Neulasta for treatment of neutropenia; also a biobetter relative to Neupogen

VEGF mAb, rDNA [Beovu - brolucizumab-dbll] approval granted on 10/7/2019 to Novartis for treatment of neovascular (wet) age-related macular degeneration (AMD)

PTH (11-34), rDNA [Bonsity - teriparatide; parathyroid hormone; PF708] approval granted 505(b)(2) to Pfenex Inc. as a biosimilar-like generic NDA drug approval with Forteo as the reference product on 10/4/2019 to for treatment of osteoporosis

Poxvirus vaccine [Jynneos - Smallpox and Monkeypox Vaccine, Live, Non-Replicating; MVA-BN; Modified Vaccinia Ankara - Bavarian Nordic] approval granted on 9/24/2019 to Bavarian Nordic A/S for prevention of disease from smallpox and monkeypox infection

glucagon-like peptide-1 , rDNA [Rybelsus - semaglutide; GLP-1] approval granted on 9/20/2019 to Novo Nordisk for treatment of type 2 diabetes; a biobetter relative to Victoza

glucagon, rDNA [Gvoke HypoPen; Gvoke Ready-to-Use Injection - glucagon] approval granted on 9/10/2019 to Xeris Pharmaceuticals for treatment of severe hypoglycemia in diabetic patients [NDA or PMA approval???]

TNF mAb, rDNA [Hadlima - adalimumab-bwwd] approval granted on 7/23/2019 as as biosimilar of Humira to Samsung Bioepis (j.v. of Samsung and Biogen), with US marketing by Merck & Co., for treatment of multiple of Samsung Bioepis's approved indications (heumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis)

CD20 mAb, rDNA [Ruxience - rituximab-pvvr] approval granted on 7/23/2019 as as biosimilar of Rituxan to Pfizer for treatment of multiple of Rituxan's approved indications (for cancer treatment)

insulin, rDNA [Myxredlin - Insulin Human in 0.9% Sodium Chloride Injection] approval granted on 7/22/2019 to Baxter for treatment of diabetes; could be considered a biobetter relative to one of the approved regular insulin products [NDA approval]

glucagon, rDNA [Baqsimi Nasal Powder - glucagon] approval granted on 7/20/2019 to Eli Lilly & Co. for treatment of severe hypoglycemia in diabetic patients (as nasal spray formulation) [NDA approval]

immunoglobulin [Xembify - immune globulin subcutaneous, human- klhw] approval granted on 7/3/2019 to Grifols for treatment of primary immunodeficiencies

VEGF mAb, rDNA [Zirabev - bevacizumab-bvzr] approval granted on 6/20/2019 to Pfizer as a biosimilar of Avastin for treatment of colorectal cancer, nonsquamous non–small cell lung cancer (NSCLC), glioblastoma, metastatic renal cell carcinoma, and cervical cancer

Her-2 mAb, rDNA [Kanjinti - trastuzumab-anns] approval granted on 6/13/2019 to Amgen (along with Allergan) as a biosimilar of Herceptin for treatment of HER2-positive breast cancer and gastric cancer.

CD79b mAb-PAL ADC, rDNA [Polivy - polatuzumab vedotin-piiq; DCDS4501A; RG7596; CD79b mAb--maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) linker--MMAE toxin] approval granted on 6/10/2019 for this antibody-drug conjugate (ADC) to Genentech/Roche for treatment of diffuse large B-cell lymphoma (DLBCL) (in combination with bendamustine plus Rituxan)

survival motor neuron 1 (SMN1) gene therapy, rDNA [Zolgensma - onasemnogene abeparvovec-xioi] approval granted on 5/24/2019 to AveXis, a subsidiary of Novartis, for treatment of pediatric patients with spinal muscular atrophy (SMA)

Dengue virus vaccine, live [Dengvaxia - Dengue Tetravalent Vaccine, Live] approval granted on 5/1/2019 to Sanofi Pasteur for the prevention of dengue disease

TNFr-Fc fusion protein, rDNA [Enticovo - etanercept-ykro] approval as a biosimilar of Enbrel granted on 4/25/2019 to Samsung Bioepis Co. for treatment the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis

IL-23 mAb, rDNA [Skyrizi - risankizumab-rzaa; interleukin-23 monoclonal antibody, recombinant] approval granted on 4/23/2019 to Abbvie for treatment of plaque psoriasis

sclerostin mAb, rDNA [Evenity - romosozumab-aqqg; AMG 785] approval granted on 4/9/2019 to Amgen for treatment osteoporotic fracture

IVIG [Asceniv - Immune Globulin Intravenous, Human-slra 10% Liquid; RI-002; immune globulin intravenous, human – slra] approval granted on 4/1/2019 to ADMA Biologics, Inc for treatment of primary humoral immunodeficiency disease; could be considered a biobetter relative to other IVIG products

Her receptor mAb, rDNA [Trazimera - trastuzumab-qyyp] approval as biosimilar of Herceptin granted on 3/11/2019 to Pfizer for treatment of breast cancer

Her mAb plus hyaluronidase, rDNA [Herceptin Hylecta - trastuzumab and hyaluronidase-oysk] granted on 2/28/2019 to Genentech/Roche for treatment of breast cancer

Factor VIII, PEG-, rDNA [Esperoct - turoctocog alfa pegol, N8-GP; antihemophilic factor (recombinant), glycopegylated-exei] granted on 2/19/2019 to Novo Nordisk for treatment of hemophilia

von Willebrand's Factor mAb. rDNA [Cablivi - caplacizumab-yhdp; VWF mAb] approval granted on 2/6/2019 to Ablynx, with marketing by Sanofi, or treatment of acquired thrombotic thrombocytopenic purpura (aTTP)

Botulinum toxin A [Jeuveau - prabotulinumtoxinA-xvfs; botulinum toxin type A] approval granted on 2/1/2019 to Evolus, Inc. for treatment of glabellar lines; considered a biobetter relative to BOTOX cosmetic

Her reecptor mAb. rDNA [Ontruzant - trastuzumab-dttb; SB3] approval granted on 1/16/2019 as a biosimilar of Herceptin (the 3rd one of these) to Samsung Biologics

2018 [2 below are not considered to be biopharmaceuticals/biologics]

DTaP-Hb-HBV, rDNA vaccine [Vaxelis - Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine] hexavalent vaccine approval granted on 12/26/2018 to Sanofi Pasteur (developed jointly with Merck & Co.) for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (but not to be launched in U.S. until 2020) [Note, despite approval as a biologic, no random 4-letter suffix was appended by FDA to be part of the proper name].

C5 mAb. rDNA [Ultomiris - ravulizumab-cwvz] approval granted on 12/21/2018 to Alexion Pharmaceuticals for treatment of adult patients with paroxysmal nocturnal hemoglobinuria

CD123 mAb, rDNA/diphtheria immunotoxin, rDNA rDNA [Elzonris - tagraxofusp-erzs; SL-401; CD123 monoclonal antibody-cytotoxin conjugate] approval granted on 12/21/2018 to Stemline Therapeutics for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Asparagnaase, rDNA, PEG- [Asparlas - calaspargase pegol-mknl] approval granted on 12/20/2018 to Servier Pharmaceuticals LLC for treatment of acute lymphoblastic leukemia (ALL)

HER receptor mAb, rDNA [Herzuma - trastuzumab-pkrb] approval granted as a biosimilar of Herceptin on 12/15/2018 to Celltrion (manufacturing) and Teva (marketing) for all of Herceptin's approved indications (e.g., for treatment of breast cancer) other than HER2-positive gastric cancer

Immune Globulin, Subcutaneous [Cutaquig - Immune Globulin Subcutaneous (Human)-hipp] approval granted on 12/12/2018 to Octapharma Pharmazeutika Produktionsges.m.b.H. treatment of primary humoral immunodeficiency (PI)

CD20 mAb, rDNA [Truxima - rituximab-abbs; CT-P10] approval granted as a biosimilar of Rituxan on 11/28/2018 to Celltrion with a 'skinny label' (for a good number of Rituxan's indications, e.g., for treatment of non-Hodgkin's lymphoma)

Interferon-gamma mAb, rDNA [Gamifant - emapalumab-lzsg; NI-0501] approval granted a on 11/20/2018 to Novimmune SA (with marketing by Swedish Orphan Biovitrum AB/Sobi) for the treatment of hemophagocytic lymphohistiocytosis (HLH)

G-CSF, PEG-, rDNA [Udenyca - pegfilgrastim-cbqv] approval granted as biosimilar of Neulasta on 11/2/2018 to Coherus BioSciencess (manuf. by KBI Biopharma) for all of Neulasta's (reference product) indications (neutropenia from cancer treatment)

TNF mAb, rDNA [Hyrimoz - adalimumab-adaz] approval granted as a biosimilar of Humira on 10/31/2018 to Sandoz/Novartis for all of Humira's (reference product) indications (e.g., rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis)

adenosine deaminase, PEG-, rDNA [Revcovi - elapegademase-lvlr] approval granted on 10/5/2018 to Leadiant Biosciences (formerly Sigma-Tau Pharmaceutical) for the treatment of adenosine deaminase-severe combined immunodeficiency (ADA-SCID) [essentially a biobetter version of Adagen]

transthyretin (TTR) antisense drug [Tegsedi - inotersen] approval granted on 10/5/2018 to Akcea Therapeutics, Inc., Ionis Pharmaceuticals, Inc., for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults; a synthetic antisense oligounucleotide drug, not a biopharmaceutical/biologic; NDA approval

PD-1 mAb, rDNA [Libtayo - cemiplimab-rwlc] approval granted on 9/28/2018 to Regeneron Pharmaceuticals, Inc. (with marketing also by Sanofi) for treatment of cutaneous squamous cell carcinoma (CSCC)

calcitonin gene-related peptide (CGRP) mAb, rDNA [Emgality - galcanezumab-gnlm] approval granted on 9/27/2018 to Eli Lilly & Co. for the treatment of migraine

calcitonin gene-related peptide (CGRP), rDNA [Ajovy - fremanezumab-vfrm] approval granted on 9/14/2018 to Teva (manufactured by Celltrion) for the treatment of migraine

CD22 immunotoxin, rDNA [Lumoxiti - moxetumomab pasudotox-tdfk] approval granted on 9/13/2018 to AstraZeneca for the treatment of hairy cell leukemia (HCL)

Factor VIII, rDNA [Jivi - antihemophilic factor [recombinant] PEGylated-aucl; BAY94-9027] approval granted on 8/30/2018 to Bayer Corp. for the prophylactic treatment of hemophilia A

kallikrein mAb, rDNA [Takhzyro - lanadelumab-flyo; SHP643; OR034] approval granted on 8/23/2018 to Dyax Corp., Shire plc, for the treatment of types I and II hereditary angioedema (HAE)

nerve growth factor, rDNA - [Ovexerate] approval on 8/22/2018 granted to Dompe farmaceutici SpA for the treatment of neurotrophic keratitis

transthyretin (TTR) RNAi [Oxervate - cenegermin-bkbj encased in lipid nanoparticle] approval of this small interfering ribonucleic acid (siRNA) [a synthetic drug, not a biologic/biopharmaceutical] granted on 8/22/2018 to Alnylam Pharmaceuticals, Inc. for the treatment of neurotrophic keratitis

siRNA-lipid complex [Onpattro - patisiran; double-stranded small interfering ribonucleic acid (siRNA), formulated as a lipid complex] synthetic (not a biologic/biopharmaceutical); approval granted on 8/10/2018 to Alnylam Pharmaceuticals, Inc. for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients

CCR-4 mAb, rDNA [Poteligeo - mogamulizumab-kpkc] approval granted on 8/8/2018 to Kyowa Kirin (with Ultragenyx) for treatment of relapsed or resistant mycosis fungoides (MF) or Sezary syndrome (SS)

Immune Globulin Intravenous [PANZYGA - Immune Globulin Intravenous (Human)-ifas] approval granted on 8/2/2018 to Octapharma Pharmazeutika Produktionsges.m.b.H. for treatment of immune thrombocytopenic purpura (ITP)

G-CSF, rDNA [Nivestym - filgrastim-aafi; granulocyte-colony stimulating factor, N-L-methionyl-] approval as biosimilar of Neupogen granted on 7/18/2018 to Pfizer for treatment of adverse effects, e.g., neutropenia, in patients receiving chemotherapy

Albumin, Human [Human Albumin Solution (HAS) - Albumin, human-kjda] approval granted on 6/19/2018 to Bio Products Laboratory for treatment of hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardiopulmonary bypass

G-CSF, rDNA, PEG- [Fulphila; pegfilgrastim-jmdb; filgrastim, recombinant pegylated; MYL-1401H; granulocyte-colony stimulating factor, N-L-methionyl-, PEG-] approval as biosimilar of Neulasta granted on 6/4/2018 to Mylan GmbH for treatment of adverse effects, e.g., neutropenia, in patients receiving chemotherapy

phenylalanine ammonia lyase], PEG-, rDNA [Palynziq - pegvaliase-pqpz4; PEGylated recombinant phenylalanine ammonia lyase] granted on 5/24/2018 to BioMarin for treatment of phenylketonuria (PKU)

CGRP mAb, rDNA [Aimovig; erenumab-aooe] approval for this calcitonin gene-related peptide (CGRP) inhibitor granted on 5/17/2018 to Amgen (with co-marketing by Novartis) for prevention of migraine in adults

EPO, rDNA [Retacrit - epoetin alfa-epbx] approval granted on 5/17/2018 to Hospira, Pfizer Inc., as a biosimilar to Epogen/Amgen and Procrit/J&J (epoetin alfa) for the treatment of or all indications of the reference product (anemia)

Cryoprecipitate - [Plasma Cryoprecipitate (For Further Manufacturing Use)] approval granted on 5/3/2018 to Octapharma Pharmazeutika Produktionsges.m.b.H. to be used as starting material for [redacted] products

Factor Xa, rDNA [Andexxa - coagulation factor Xa (recombinant), inactivated-zhzo] approval granted on 5/3/2018 to Portola Pharamceuticals when reversal of anticoagulation is needed

FGF-23 mAb, rDNA [Crysvita - burosumab-twza; fibroblast growth factor 23 monoclonal antibody] approval granted on 4/17/2018 to Ultragenyx Pharmaceutical Inc. (dev. in collaboration with Kyowa Hakko Kirin) for treatment of x-linked hypophosphatemia (XLH), a rare inherited form of rickets

IL-23 mAb, rDNA [Ilumya - tildrakizumab-asmn] approval granted on 3/20/2018 to Sun Pharmaceutical Industries Ltd. (India; under exclusive license granted by Merck & Co.) for treatment of plaque psoriasis

CD4 mAb, rDNA [Trogarzo - ibalizumab-uiyk; T-cell CD4 receptor monoclonal antibody] approval granted on 3/6/2018 to TaiMed Biologics (Taiwan/ROC) for treatment of HIV-infection, with manufacture by WuXi Biologics (China/PRC); originally developed by Tanox (US), licensed to TaiMed by Genentech/Roche after its acquisition of Tanox

2017

RPE65, AAV2 vector [Luxturna - voretigene neparvovec-rzyl; AAV2-hRPE65v2; SPK-RPE65], an allogeneic gene therapy, granted on 12/19/2017 to Spark Therapeutics Inc. for treatment of vision loss/blindness due to biallelic RPE65 mutation-associated retinal dystrophy (Leber's congenital amaurosis)

TNF mAb, rDNA [Ixifi - infliximab-qbtx] biosimilar BLA approval based on Infliximab as the reference product granted on 12/13/2017 to Pfizer [technically granted to Hospira, which was acquired by Pfizer] for treatment of the many indications approved for Infliximab, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, etc.

insulin lispro, rDNA [Admelog] 505(b)(2) drug approval [biosimilar-like generic drug approval based on Humalog as the reference product] granted on 12/5/2017 to Sanofi-Aventis U.S. for treatment of diabetes

GLP-1 analog, rDNA [Ozempic - semaglutide] NDA (drug) approval granted on 12/5/2017 to Novo Nordisk for treatment of diabetes [Note: yeast expressed backbone with multiple chemical modifications]

HER receptor mAb, rDNA [Ogivri - trastuzumab-dkst; MYL-1401O] approval as biosimilar (of Herceptin) granted on 12/1/2017 to Mylan and Biocon for treatment of breast or stomach cancer

Factor VIII mAb, rDNA [Hemlibra - emicizumab-kxwh] approval granted on 11/16/2017 to Genentech/Roche for treatment of hemophilia A with factor VIII inhibitors

beta-glucuronidase, rDNA [Mepsevii - vestronidase alfa-vjbk] approval granted on 11/15/2017 to Ultragenyx Pharmaceutical for treatment of inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII; Sly syndrome)

IL-5r mAb, rDNA [Fasenra - benralizumab; interleukin-5 receptor (CD125) monoclonal antibody] approval granted on 11/14/2017 to MedImmune/AstraZeneca (licensed from BioWa, Inc., subsidiary of Kyowa Hakko Kirin Co., Ltd.) for treatment of asthma

Hepatitis B vaccine, rDNA [HEPLISAV-B] approval granted on 11/9/2017 to Dynavax Technologies Corp for prevention of hepatitis B virus infection

Fibrin Sealant [no trade name upon approval] approval granted on 11/1/2017 to Instituto Grifols, S.A. for topical control of bleeding

VZV vaccine, rDNA, AS01B (MPL and QS-21) adjuvant [Shingrix - Zoster Vaccine Recombinant, Adjuvanted; recombinant subunit vaccine with AS01B adjuvant (bacteria-derived monophosphoryl lipid A and QS-21 saponin) approval granted on 10/20/2017 to GlaxoSmithKline (GSK) for prevention of shingles (herpes zoster)

CAR-T cells autologous, rDNA [Yescarta - axicabtagene ciloleuce; a CAR-T cellular/gene therapy] approval granted on 10/18/2017 to Kite Pharma, Inc./Gilead for the treatment of relapsed or refractory large B-cell lymphoma

insulin aspart, rDNA [Fiasp; faster acting insulin aspart] approval granted on 9/29/2017 to Novo Nordisk for the treatment of diabetes types 1 and 2

VEGF mAb, rDNA [Mvasi - bevacizumab-awwb] biosimilar approval granted on 9/14/2017 to Sanofi for the treatment of certain colorectal, lung, brain, kidney and cervical cancer

CAR-T cells, autologous, rDNA [Kymriah - tisagenlecleucel; T-cells, with a chimeric antigen receptor (CAR) gene insert] approval granted on 8/30/2017 to Novartis for the autologous gene therapy-modified T-cell treatment of B-cell precursor acute lymphoblastic leukemia (ALL) refractory or in second or later relapse

rabies IG [Kedrab - rabies immune globulin (Human)] approval granted on 8/23/2017 to Kedrion Biopharma [and Kamada Ltd.]for passive transient post-exposure prophylaxis of rabies infection

TNF-alpha mAb, rDNA [Cyltezo - adalimumab-adbm] biosimilar approval granted on 8/25/2017 to Boehringer Ingelheim for the treatment of diabetes, with Humira as the reference product.

CD22 mAb, rDNA [Besponsa - inotuzumab ozogamicin] approval granted on 8/17/2017 to Pfizer for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

insulin glargine , rDNA [Lusduna Nexvue] approval granted on 7/24/2017 to Merck & Co., Inc. [with Samsung also involved] for treatment of diabetes. Note, a tentative [awaiting patent dispute resolution] 505[b][2] generic drug approval (but everyone will likely refer to is as a biosimilar)

IL-23 mAb, rDNA [Tremfya - guselkumab] approval granted on 7/13/2017 to Janssen Biotech, Inc., a division of Johnson & Johnson for treatment of plaque psoriasis.

CD19 mAb, rDNA [blinatumomab - Blincyto] approval granted on 7/11/2017 to Amgen for treatment of relapsed or refractory b-cell precursor acute lymphoblastic leukemia (ALL)

Rituximab and hyaluronidase [Rituxan Hycela] approval granted on 6/23/2017 to Hoffmann La-Roche for or subcutaneous (under the skin) injection, for the treatment of relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukaemia (CLL)

C1 Esterase Inhibitor Subcutaneous (Human) [HAEGARDA; CSL830; C1 Esterase Inhibitor Subcutaneous (Human)] approval granted on 6/22/2017 to CSL Behring to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients

Fibrinogen [Fibryna - Fibrinogen (Human)] approval granted on 6/7/2017 to Octapharma Pharmazeutika Produktions GmbH for treatment of congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Factor IX, PEG-, rDNA [Rebinyn - nonacog beta pegol; Coagulation Factor IX (Recombinant), GlycoPEGylated; N9-GP] approval granted on 5/31/2017 to Novo Nordisk for treatment of hemophilia B

IL-6r mAb, rDNA [Kevzara - sarilumab; interleukin-6 receptor mmonoclonal antibody] approval granted on 5/22/2017 to Kevzara to Regeneron and Sanofi Genzyme for treatment of severely active rheumatoid arthritis (RA)

IL-6r mAb, rDNA [Tecentriq - atezolizumab; programmed death-ligand 1 mmonoclonal antibody] approval granted on 5/18/2016 to Kevzara to Genentech/Roche for treatment of advanced urothelial carcinoma; the treatment of metastatic non-small cell lung cancer (NSCLC); extensive-stage small cell lung cancer; and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer

PD-1r mAb, rDNA [Imfinzi - durvalumab; programmed cell death ligand 1 (PD-L1) receptor mmonoclonal antibody] approval granted on 5/1/2017 to MedImmkune/AstraZeneca for treatment of urothelial carcinoma

tripeptidyl peptidase 1, rDNA [Brineura - cerliponase alfa; TPP1; BMN 190] approval granted on 4/27/2017 to BioMarin Pharmaceutical Inc. for the treatment of a specific form of Batten disease

TNF mAb fragment, rDNA [Renflexis - infliximab-abday] approval granted as biosimilar of Remicade on 4/21/2017 to Merck & Co. with manufacture by Samsung in S. Korea,. for the treatment of Remicade's approved indications

IL-4RA mAb, rDNA [Dupixent - dupilumab; interleukin-4 receptor alpha subunit monoclonal antibody] approval granted on 3/28/2017 to Sanofi and Regeneron for the treatment of moderate-to-severe eczema

CD20 mAb, rDNA [Ocrevus - ocrelizumab] approval granted on 3/28/2017 to EMD Genentech/Roche for the treatment of primary progressive form of multiple sclerosis (PPMS)

PD-L1 mAb, rDNA [Bavencio - avelumab; anti-PD-L1 MSB0010718C] approval granted on 3/25/2017 to EMD Serono Inc., Merck KGaA, for the treatment of metastatic Merkel cell carcinoma (MCC; a skin cancer)

IL-7ra mAb, rDNA [Siliq - brodalumab; interleukin-17 receptor A (IL-17RA) monoclonal antibody, recombinant] approval granted on 2/15/2017 to Valeant Pharmaceuticals for the treatment of moderate-to-severe plaque psoriasis

2016

nusinersen (antisense) [Spinraza]; Note, a synthetic antisense oligonucleotide, which is not a biopharmaceutical by most definitions; approval granted on 12/23/2016 to Biogen for treatment of spinal muscular atrophy (SMA)
insulin glargine, rDNA [Basaglar] full NDA drug approval granted on 12/16/2016 to Eli Lilly for treatment of type 2 diabetes
insulin deglude plus liraglutide, rDNA [Xultophy 100/3.6 combination treatment; Tresiba plus Victoza] NDA pproval granted on 11/21/2016 to Novo Nordisk for treatment of type 2 diabetes; Note, 1st approval for this combination treatment, not for the 2 components.
lixisenatide plus insulin glargine, rDNA [Soliqua 100/33 combination treatment; Lantus plus Lyxumia (EU); Lantus plus Adlyxin (US)] approval granted on 11/21/2016 to Sanofi for treatment of type 2 diabetes; Note, 1st approval for this combination treatment, not for the 2 components
Clostridium difficile mAb, rDNA [Zinplava; bezlotoxumab] approval granted on 10/21/2016 to Merck & Co. to reduce recurrence of Clostridium difficile infection
PDGF mAb, rDNA [Lartruvo - olaratumab; platelet-derived growth factor monoclonal antibody] accelerated approval granted on 10/19/2016 to Eli Lilly & Co. for treatment of advanced soft tissue sarcoma in combination with doxorubicin
Influenza vaccine, quadravalent [Flublok] approval granted on 10/11/2016 to Protein Sciences Corp. for influenza prophylaxis
TNF mAb, rDNA [Amjevita - adalimumab-atto] approval as a biosimilar of Humira granted to Amgen on 9/23/2016 for all of Humira's approved indications
Eteplirsen (antisese) [Exondys 51; AVI-4658,]; Note, a synthetic a morpholino phosphorodiamidate antisense oligomer (antisense drug), which is not be a biopharmaceutical by most definitions; approval granted on 9/19/2016 to Sarepta Therapeutics Inc. for treatment of Duchenne muscular dystrophy
Immune globulin, s.c. [Cuvitru - immune globulin subcutaneous (human) 20% solution] approval granted on 9/14/2016 to Shire for treatment of primary immunodeficiencies
TNFr-Fc fusion protein [Erelzi - etanercept] biosimilar approval granted on 8/26/2016 to Sandoz/Novartis with same indications as Enbrel, including rheumatoid arthritis, psoriasis and other immune system disorders
Cholera vaccine, live [Vaxchora] granted on 6/10/2016 to PaxVax for oral prevention of cholera (with manufacture by SynCo Bio Partners as CMO)
lixisenatide, rDNA [Adlyxin] approval granted on 7/28/2016 to Sanofi for treatment of type 2 diabetes
IL-2 receptor mAb, rDNA [Zinbryta; daclizumab] granted on 5/27/2016 to Biogen for treatment of relapsing multiple sclerosis
Factor VIII, single-chain, rDNA [Afstyla] granted on 5/25/2016 to CSL Behring for treatment hemophilia A
TNF mAb, rDNA [Inflectra - infliximab-dyyb)] granted on 4/5/2016 to Janssen/Johnson & Johnson as a biosimilar of Remicade, including extrapolation of all of Remicade's current approved indications; manufactured by Celltrion
Polydeoxyribonucleotides, porcine-derived [Defitelio - defibrotide sodium; polydeoxyribonucleotide, sodium salt] granted on 3/30/2016 to Jazz Pharmaceuticals for treatment of hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after receiving a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT)
IL-5 Mab, rDNA [Cinqair; reslizumab] granted on 3/23/2016 to Teva for treatment of severe eosinophilic asthma
IL-17 Mab, rDNA [Taltz; ixekizumab] granted on 3/22/2016 to Eli Lilly & Co. for treatment of adults with moderate-to-severe plaque psoriasis
Anthrax Mab, rDNA [Anthim; Bacillus anthracis (anthrax) Protective Antigen (PA) monoclonal antibody, recombinant; obiltoxaximab; ETI-204] granted on 3/18/2016 to Elusys Therapeutics, Inc. for prophylaxis against inhalational anthrax infection [for the U.S. biodefense Strategic National Stockpile (SNS)]
Factor VIII. rDNA [Kovaltry; Antihemophilic Factor (Recombinant)] granted on 3/17/2016 to Bayer AG for treatment of hemophilia [with less frequent injections required]
Factor IX-Albumin, rDNA [Idelvion; Coagulation Factor IX (Recombinant), Albumin Fusion Protein] granted on 3/4/2016 to CSL Behring for control and prevention of bleeding

2015

insulin glargine. rDNA [Basaglar; Abasria; LY2963016] granted on 12/16/2015 to Boehringer Ingelheim for treatment of diabetes; Note, a 505(b)(2) drug approval, which many would now call a biosimilar
Faxtor X, blood-derived [Coagadex; Coagulation Factor X (Human)] granted on 12/16/2015 to Bio Products Laboratory Ltd. for treatment of for hereditary Factor X deficiency
von Willebrand factor, rDNA [Vonvendi] granted on 12/9/2015 to Baxalta U.S. (formerly Baxter) for treatment of von Willebrand's disease (VWD)
lyosomal acid lipase, chicken egg-expressed [Kanuma; sebelipase alfa] granted on 12/8/2015 to Alexion (from acquisition of Synageva) for treatment of lyosomal acid lipase (LAL) deficiency [2nd product from genetically engineered animals]
Influenza vaccine, quadravelent [Fluad; influenza vaccine, inactivated, egg-cultured, quadravelent with MF59/squalene adjuvant] granted on 12/3/2015 to Novartis (with product and its approval to be transferred to Seqirus, part of CSL Group) for prevention of influenza; first U.S. non-aluminum-based adjuvanted influenza vaccine
SLAMF7 mAb, rDNA [Empliciti; elotuzumab; Signaling Lymphocyte Activation Molecule Family member 7 monoclonal antibody, recombinant] granted on 11/30/2015 to Bristol Myers Squibb (BMS; with Abbvie) for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1-3 prior therapies
EGFr mAb, rDNA [Portrazza - necitumumab; epidermal growth factor receptor monoclonal antibody] granted on 11/24/2015 to Janssen Biotech for treatment of metastatic squamous non-small cell lung cancer(VWD) in combination with gemcitabine and cisplatin
CD38 mAb, rDNA Darzalex Faspro - daratumumab and hyaluronidase-fhji] granted on 11/16/2015 to Eli Lilly for treatment of multiple myeloma
Factor VIII, rDNA, pegylated [Adynovate - BAX 111] granted on 11/11/2015 to Baxalta (formerly Baxter) for treatment of hemophilia A
IL-5 mAb, rDNA [Nucala; mepolizumab] granted on 11/4/2015 to GlaxoSmithKline (GSK) for treatment of asthma
HSV-1/GM-CSF, rDNA, rDNA [Imlygic - alimogene laherparepvec; a live herpes simplex virus type 1 (HSV-1) oncolytic virus resulting in expression of GM-CSF] granted on 10/27/2015 to Alexion Pharmaceuticals for treatment of unresectable recurrent cutaneous melanoma
alkaline phosphatase, rDNA [Strensiq; asfotase alfa; an alkaline phosphatase catalytic domain fusion protein] granted on 10/23/2015 to Alexion Pharmaceuticals for treatment of perinatal, infantile and juvenile-onset hypophosphatasia (HPP)
dabigatran mAb, rDNA [Praxbind - idarucizumab] granted on 10/16/2015 to Boehringer Ingelheim to reverse the blood-thinning effects of Pradaxa (dabigatran)
insulin degludec, rDNA [Tresiba - insulin degludec] granted on 10/16/2015 to Novo Nordisk for treatment of diabetes mellitus
insulin degludec/aspart, rDNA [Ryzodeg 70/30 - a 70/30 mixture of insulin degludec (approved the same day) and insulin aspart] granted on 10/16/2015 to Novo Nordisk for treatment of diabetes mellitus
Factor VIII, rDNA [Nuwiq] granted on 10/16/2015 to Octapharma USA for treatment of hemophilia A
PCSK9 mAb, rDNA [Repatha - evolocumab; proprotein convertase subtilisin kexin type 9 monoclonal antibody] approval granted on 8/27/2015 to Amgen Inc. for treatment of high low-density lipoprotein (LDL) cholesterol levels
PCSK9 mAb, rDNA [Praluent - alirocumab; proprotein convertase subtilisin kexin type 9 monoclonal antibody] approval granted on 7/24/2015 to Sanofi and Regeneron Pharmaceuticals for treatment of high low-density lipoprotein (LDL) cholesterol levels
Crotalidae Immune F(ab')2 (Equine) [Anavip] approval granted on 5/6/2015 to ProFibrix, BV with manufacture by Instituto Bioclon S.A. (Mexico) for treatment of North American rattlesnake bites
Fibrin Sealant [RAPLIXA; RaplixaSpray - human plasma-derived fibrinogen and thrombin] approval granted on 4/30/2015 to The Medicines Company (originally developed by ProFibrix, BV, which was acquired) for treatment of mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical.
Factor IX, rDNA [Coagulation Factor IX (Recombinant) - Ixinity] approval granted on 4/29/2015 to Cangene/Emergent Biosolutions for treatment of hemophilia B
DTaP-IPV vaccine [Quadracel - Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus] approval granted on 3/26/2015 to Sanofi Pasteur for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age
anthrax immune globulin [Anthrax Immune Globulin Intravenous (Human) - Anthracil; AIGIV] approval granted on 3/24/2015 to Emergent BioSolutions Inc. for treatment of inhalational anthrax in combination with appropriate antibacterial drugs
GD2 mAb, rDNA [dinutuximab - Unituxin; ch14.18] approval granted on 3/10/2015 to United Therapeutics Corp. [in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA)] for the treatment of pediatric patients with high-risk neuroblastoma
G-CSF, rDNA/Sandoz [filgrastim-sndz - Zarxio; Zarzio; Granulocyte Colony Stimulating Factor, recombinant] approval granted on 3/6/2015 to Sandoz/Novartis; first biosimilar approval; for treatment of neutropenia (same indications as Neupogen)
PD-1 mAb, rDNA/Sandoz [nivolumab - Opdivo; ONO-4538; BMS-936558; MDX1106; programmed cell death 1 monoclonal antibody, recombinant] approval granted on 3/4/2015 to Bristol-Myers Squibb Co. (BMS; licensed from Ono Pharm.) for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
Insulin glargine, rDNA [Toujeo - Gly(A21)-human Insulin Arg(B31)-Arg(B32)-OH, recombinant] approval granted on 2/25/2015 to Sanofi for once-daily long-acting basal insulin treatment in adults living with type 1 and type 2 diabetes
Parathyroid hormone (1-84), rDNA [Natpara; Preos; Preotact] approval granted on 1/25/2015 to NPS Pharmaceuticals, being acquired by Shire, for treatment ot hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism
Neisseria meningitidis vaccine [secukinumab - Bexsero; Cosentyx] approval granted on 1/23/2015 to Novartis for prevention of invasive meningococcal disease
IL-17 mAb, rDNA [secukinumab - Cosentyx] approval granted on 1/21/2015 to Novartis for treatment of adults with moderate to severe plaque psoriasis

2014

programmed death receptor-1 mAb, rDNA [nivolumab - Opdivo] approval granted on 12/22/2014 to Bristol-Myers Squibb for treatment of advanced melanoma (for patients with unresectable or metastatic melanoma and disease progression after treatment with Yervoy, is patients with BRAF V600 mutation positive tumors)
Influenza Vaccine, 4-valent, i.d. [Fluzone Intradermal Quadrivalent] approval granted on 12/12/2014 to Sanofi Pasteur for prophylactic use in adults age 18-64
[Note, this was as supplemental BLA (sBLA) approval. This was despite this being a totally new, different/unique product (technically), i.e., having novel active agents and formulation (4 vs. usual 3 antigens) and tested/proven more effective vs. 3-valent vaccine in a large Phase III trial. Any recombinant or therapeutic biologic adding another functional component would presumably require a full BLA. Just another of many incongruities in how biologics are regulated by FDA.]
HPV vaccine, 9-valent, rDNA [Human Papillomavirus 9-valent Vaccine, Recombinant - Gardasil 9] approval granted on 12/10/2014 to Merck & Co. for prophylactic use in females age 9-26
CD3-CD19 bi-specific mAb, rDNA [blinatumomab - AMG103; CD19-CD3 bispecific monoclonal antibody; CD3-CD19bi-specific T-cell engager (BiTE)] accelerated approval granted on 12/03/2014 to Amgen for treatment of Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL); breakthrough therapy designation
meningococcal B vaccine [meningococcal group B vaccine - Trumemba] accelerated approval granted on 10/29/2014 to Pfizer for active immunization to prevent invasive Neisseria meningitidis serogroup B in those 10-25 years of age
Factor VIII, porcine rDNA [Antihemophilic Factor (Recombinant), Porcine (pig) Sequence - Obizur; OBI-1; Factor VIII, porcine recombinant] approval granted on 10/24/2014 to Baxter for treatment of adult patients with adults with acquired (not-hereditary) hemophilia A
glucagon-like peptide-1, rDNA [Trulicity] approval granted on 9/18/2014 to Eli Lilly & Co. for treatment of adult patients with adults with type 2 diabetes
Immune Globulin & Hyaluronidase rDNA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase - HYQVIA; Gammagard combined with Hylenex] approval granted on 9/12/2014 to Baxter (and Halozyme Therapeutics) for treatment of adult patients with primary immunodeficiency (PI)
PD-1 mAb, rDNA [Keytruda - pembrolizumab; MK-3475] approval granted on 9/4/2014 to Merck & Co. for treatment of patients with advanced melanoma not responding to other therapies.
insulin glargine, rDNA/Lilly [Basaglar] tentative approval granted on 8/18/2014 to Eli Lilly & Co., partnered with Boehringer Ingelheim, for the treatment of diabetes
Note, this is a 505(b)(2) filing for generic drug approval, with insulins still subject to regulation as drugs, not biologics. Contrary to press reports, this is not a biosimilar product or approval (in the U.S.).
interferon beta-1a, PEG-, rDNA [Plegridy] granted on 8/15/2014 to Biogen Idec for the treatment of relapsing forms of multiple sclerosis (RMS)
C1-esterase inhibitor, rDNA [conestat alfa - Rhucin; Ruconest; C1INH; C1-INH; human complement C1 esterase inhibitor, recombinant, transgenic rabbits] granted on 7/17/2014 to Salix Pharmaceuticals, Ltd. (and Pharming Group NV) for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE)
Insulin, rDNA, inhaled/MannKind [insulin human [rDNA origin]) Inhalation Powder - Afrezza; Afresa Inhalation Powder; Technosphere insulin] granted on 6/27/2014 to MannKind Corp, to improve glycemic control in adults with diabetes mellitus
Factor VIII/Biogen-Idec, rDNA [Eloctate] granted on 6/6/2014 to Biogen Idec Inc. for treatment of hemophilia A
integrin mAb, rDNA [Entyvio - vedolizumab] granted on 5/20/2014 to Takeda Pharmaceuticals America, Inc. for treatment of ulcerative colitis and Crohn's disease
IL-6 mAb, rDNA [Sylvant - siltuximab; CNTO 328] granted on 4/23/2014 to Janssen/J&J for treatment of multicentric Castleman's disease (MCD)
VEGF-2 mAb, rDNA [VEGRFr mAb - Cyramza; ramucirumab] granted on 4/21/2014 to Eli Lilly & Co. for treatment of advanced gastic cancers
GLP-1/Albumin fusion protein, rDNA [Tanzeum - glucagon-like peptide-1 (GLP-1)-albumin fusion protein] granted on 4/15/2014 to GlaxoSmithKline (GSK) for glycemic control in type 2 diabetes
Factor IX-Fc fusion protein, rDNA [Coagulation Factor IX (Recombinant), Fc Fusion Protein - Alprolix; Factor IX-XTEN] granted on 3/28/2014 to Biogen Idec for treatment of hemophilia B
Hyaluronic acid, cross-linked [Monovisc] granted on 2/25/2014 to Anika Therapeutics for osteoarthritis treatment of the knee
Leptin, rDNA [Metreleptin - methionyl human leptin, recombinant] granted on 2/24/2014 as replacement therapy to treat the complications of leptin deficiency
N-acetylgalactosamine-6-sulfatase, rDNA [elosulfase alfa - Vimizim; N-acetylgalactosamine-6-sulfatase; rhGALNS; BMN-110, elosulfase alfa; chondroitin sulfatase] granted on 2/14/2014 to BioMarin (marketed by DePuy Synthes, a unit of Johnson & Johnson) for treatment of mucopolysaccharidosis type IV A (Morquio A syndrome)

2013 - Note, only 11 new biopharmaceuticals approved, including 1 borderline product; 3 established products with minor variations (a new indication, and a new much the same additional vaccine antigen) are not considered new products

Factor XIII, rDNA [Coagulation Factor XIII A-Subunit (Recombinant) - Tretten] granted on 12/23/2013 to Novo Nordisk A/S for routine prevention of bleeding in adults and children with congenital Factor XIII A-subunit deficiency (hemophilia)

Influenza vaccine, H5N1 [Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted] granted on 11/22/2013 to ID Biomedical/GSK for prevention of H5N1 influenza, commonly known as avian or bird flu; Note, full BLA, but only intended for pandemic/biodefense stockpile use, granted to this egg-cultured AS03-adjuvanted vaccine.

CD20 mAb, rDNA/Roche [obinutuzumab - Gazyva; GA101] granted on 11/1/2013 to Genentech/Roche for use in combination with chlorambucil chemotherapy for the treatment of previously untreated chronic lymphocytic leukemia (CLL)

Tetanus and Diphtheria Toxoids Adsorbed [Tenivac] granted on 10/25/2013 to Sanofi for tetanus and diphtheria prevention

Factor VIII, rDNA/Novo [Antihemophilic Factor (Recombinant) - NovoEight; Factor VIII, recombinant] granted on 10/15/2013 to Novo Nordisk for treatment of hemophilia A

Influenza vaccine, quadrivalent/GSK [Flulaval Quadrivalent] granted on 8/16/2013 to GlaxoSmithKline (GSK) for influenza prophylaxis
This is the 3rd injectable 4-antigen/quadarivelent influenza vaccine. Despite obviously being a distinct and unique new product, in many respects, this was approved through a supplemental BLA, so many may not consider it a new product, just a comparable follow-on modified version of Flulaval. On the other hand, this 4-component vaccine, containing a new 4th component antigen, presumably would not even qualify as being biosimilar to the prior 3-component vaccine, so how it could receive approval through a supplemental BLA as being the 'same' as (i.e., comparable to) the prior vaccine, rather than being both physcially different and, presumably, a clinically better new product requiring full BLA approval? This is just one of many paradoxes and inconsistencies one encounters with biopharmaceutical approvals (yet another reason you need to subscribe to the database).
TNF Mab, rDNA, human/J&J [golimumab - Simponi Aria] full BLA granted on 7/18/2013 to Janssen Biotech, Johnson & Johnson for treatment of moderately to severely active rheumatoid arthritis
[Note, Simponi, the same product but with a different route of administration (infusion for Simponi Aria vs. s.c. self-injection for Simponi), was approved in 2009. This is considered a minor approval, the same product simply approved with a new indication; a type of approval classically handled by a sBLA, But here with a new full BLA, the biosimilars-related 12 years exclusivity clock is restarted].
Factor IX, rDNA/Baxter [Coagulation Factor IX (Recombinant) - Rixubis] granted on 6/27/2013 to Baxter Healthcare for treatment of hemophilia B
Influenza vaccine, quadrivalent/Sanofi [Fluzone Quadrivalent] granted on 6/10/2013 to Sanofi for influenza prophylaxis
This is the second injectable 4-antigen/quadarivelent influenza vaccine. Despite obviously being a distinct and unique new product, in many respects, this was apparently approved through a supplemental BLA, so many may not consider it a new product, just a comparable follow-on modified version of Fluzone. The commments above regarding quadrivalent vaccines being a new or not new product also apply to this product.
Prothrombin Complex/CSL [Prothrombin Complex Concentrate (Human) - Kcentra] granted on 4/29/2013 to CSL Behring GmbH for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Botulism Antitoxin/A-G [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine); Clostridium botulinum toxin immune globulin, equine] granted on 3/23/2013 to Cangene Corp. for treatment of botulism following documented or suspected exposure to botulinum neurotoxin
HER2 receptor Mab-DM1, rDNA [ado-trastuzumab emtansine - Kadcyla; trastuzumab emtansine; trastuzumab-DM1; T-DM1; trastuzumab-MCC-DM1; herceptin-DM1 conjuagate] granted on 2/22/2013 to Genentech/Roche for treatment of HER2-positive metastatic breast cancer (mBC)
apolipoprotein B, antisense [mipomersen - Kynamro; ISIS 301012] granted on 1/17/2013 to Isis Pharmaceuticals and Genzyme/Sanofi for use as an adjunct to lipid-lowering drugs and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high-density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)
[Note, as a fully-synthetic antisense phosphorothioate, this drug is considered a borderline biopharmaceutical].
Plasma SD/Octapharma [Octaplas - Plasma, solvent-detergent inactivated] granted on 1/17/2013 to Octapharma AG for needed replacement of clotting proteins (coagulation factors)
Influenza vaccine, rHA, rDNA [Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin - FluBlok; influenza hemagglutinin vaccine, insect cell-cultured, recombinant] granted on 1/17/2013 to Protein Sciences Corp., with marketing by Emergent Biosolutions, Inc., for prevention of influenza in persons 18-49 years old
[the first modern recombinant (vs. natural recombinant FluMist) influenza vaccine, the first single-antigen influenza vaccine]

2012 ; [Note, database updating essentially ended this year, with prior approvals having links into the database]

glucagon-like peptide 2, rDNA [teduglutide [rDNA origin] - GATTEX] granted on 12/21/2012 to NPS Pharmaceutical for treatment of adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition)
Immune Globulin (IGIV)/Biotest [Immune Globulin Intravenous (Human) - Bivigam] granted on 12/20/2012 to Biotest Pharmaceuticals Corp. for treatment of primary immune deficiency disorders (PIDD).
Varicella-Zoster Immune Globulin/Cangene [Varicella-Zoster Immune Globulin (Human) - VariZIG; VZVIG] granted on 12/19/2012 to Cangene Corp. for post-exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella
Fluarix Quadravalent [Influenza Virus Vaccine - Fluarix Quadravalent] granted on 12/17/2012 to GlaxoSmithKline (GSK), for prevention of disease caused by the four seasonal influenza (flu) virus subtypes A and type B strains represented by antigens in the vaccine
This is the first injectable 4-antigen/quadarivelent influenza vaccine. See the first 4-antigen/quadarivelent influenza vaccine below, which happens to be an intranasal vaccine, with its approval earlier in 2012. Despite obviously being a distinct and unique new product, in many respects, this was approved through a supplemental BLA, so many may not consider it a new product, just a comparable follow-on modified version of Fluarix. On the other hand, this 4-component vaccine, containing a new 4th component antigen, presumably would not even qualify as being biosimilar to the prior 3-component vaccine, so how it could receive approval through a supplemental BLA as being the 'same' as (i.e., comparable to) the prior vaccine, rather than being a physcially different, presumably clinicly better new product requiring full BLA approval? This is just one of many paradoxes and inconsistencies one encounters with biopharmaceutical approvals (yet another reason you need to subscribe to the database).
Anthrax Mab, rDNA/HGSI [raxibacumab - ABthrax; Bacillus anthracis protective antigen human monoclonal antibody, recombinant] granted on 12/14/2012 to Human Genome Sciences Inc., a subsidiary of GlaxoSmithKline (GSK), for treatment of inhalational anthrax and prevention of inhalational anthrax when alternative therapies are not available or not appropriate.
Fibrin Sealant Patch/J&J [Fibrin Sealant Patch-Human Fibrinogen and Human Thrombin - EVARREST Fibrin Sealant Patch] granted on 12/7/2012 to Ethicon Biosurgery, Johnson & Johnson (J&J), with manufacture by Omrix Biopharmaceuticals Ltd. (Israel) for use as an aid in stopping problematic bleeding during surgery
Influenza vaccine, MDCK cultured/Novartis [Flucelvax; Optaflu; Influenza virus vaccine, inactivated] granted on 11/20/2012 to Novartis for prevention of seasonal influenza in people ages 18 years and older [the first cell cultured influenza vaccine in the U.S.]
Microplasmin, rDNA [Ocriplasmin - Jetrea] granted on 10/18/2012 to ThromboGenics for treatment of symptomatic vitreomacular adhesion
G-CSF, rDNA/Teva [filgrastim; same active agent as Neupogen and TevaGrastin, approved as a biosimilar of Neupogen in the EU] Full BLA granted on 8/30/2012 to Sicor Biotech (Teva Pharmaceuticals) to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) receiving chemotherapy that affects the bone marrow.
So far, there is no indication of why, how, etc. FDA is using the "tbo" prefix and not using the USAN name (filgrastim).
VEGF Trap, rDNA [ziv-aflibercept - Zaltrap] granted on 8/3/2012 to Sanofi (with Regeneron) for use in combination with 5-flourouracil, leucovorin, irinotecan-(FOLFIRI) for treatment of metastatic colorectal cancer (mCRC) resistant to or having progressed following an oxaliplatin-containing regimen
Note: Zaltrap received a full BLA, but its active agent is absolutely the same as in Eylea (approved in late 2011) also developed and manufactured by Regeneron, with Zaltrap approved for a different indication and marketed by different company. So far, there is no indication of why, how, etc. FDA is using the "ziv" prefix and not using the USAN name (afibercept).
MenC-Hib vaccine [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine - MenHibrix] granted on 6/14/2012 toGlaxoSmithKline for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (a combination of prior-approved vaccines)
HER2 receptor Mab, rDNA/2C4 [pertuzumab - Perjeta; Omnitarg; 2C4] granted on 6/8/2012 to Genentech/Roche for use combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the first-line treatment of HER2-positive metastatic breast cancer
Glucocerebrosidase, rDNA/Protalix [taliglucerase alfa - Elelyso; Uplyso; beta-glucocerebrosidase, recombinant (carrot expressed); prGCD] granted on 5/1/2012 to Protalix BioTherapeutics Inc. and Pfizer (the BLA holder) for treatment of Gaucher disease [Could be considered a biobetter version of Cerezyme from Genzyme/Sanofi]
Human cells, autologous/bovine collagen substrate [Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen - GINTUIT] granted on 3/9/2012 to Organogenesis Inc. for topical application to a surgically created vascular wound bed in the treatment of mucogingival (gums; oral tissue) conditions [first cell-based product for an oral tissue application]
Pancreatic enzymes [pancrelipase - Ultresa; Viokase] granted on 3/1/2012 to Aptalis Pharma for treatment of orphan pancreatic insufficiency indications [First full approval for a long-marketed, grandfathered drug product].
Influenza vaccine, live intranasal quadravalent [FluMist Quadrivalent; Influenza Vaccine Live, Intranasal] sBLA granted on 2/29/2012 to MedImmune (AstraZeneca) for prevention of seasonal influenza
This is the first 4-antigen/quadarivelent influenza vaccine. Yet, in many respects, despite being a distinct and unique new product, this was approved through a supplemental BLA. The 4-component vaccine, containing a new 4th component antigen component, would presumably not even qualify as being biosimilar to the prior 3-component vaccine (physically different, clinically better), so how it could receive approval through a supplemental BLA as being the 'same' as (i.e., comparable to) the prior vaccine, rather than requiring full BLA approval? This is just one of many paradoxes and inconsistencies one encounters with biopharmaceutical approvals (yet another reason to subscribe to the database).
Carboxypeptidase, rDNA - [Glucarpidase - Voraxaze; CPG2; carboxypeptidase G2, recombinant] granted on 1/18/2012 to BTG plc (formerly Protherics) for treatment of methotrexate toxicity

2011

VEGF Trap, rDNA - [Aflibercept - Eylea; VEGF Trap-Eye] granted on 11/18/2011 to Regeneron Pharmaceuticals (with international marketing by Bayer) for treatment of wet (neovascular) age-related macular degeneration (AMD)
Asparaginase/Erwinia - [Erwinaze - asparaginase Erwinia chrysanthemi; Erwinase; L-asparagine aminohydrolase; L-asparaginase] granted on 11/18/2011 to EUSA Pharma Inc. for treatment of acute lymphoblastic leukemia (ALL)
cord blood stem cells - [HEMACORD; Hematopoietic progenitor cells-cord (HPC-C) cell therapy] approval granted on 11/10/2011 to the New York Blood Center, Inc. for use in hematopoietic stem cell transplantation procedures in patients with disorders affecting the hematopoietic (blood forming) system.
CD30 mAb-monomethyl auristatin E - [Adcetris; brentuximab vedotin; CD30 mAb-cytotoxin conjugate] accelerated approval with orphan status granted on 8/19/2011 to Seattle Genetics, Inc. for treatment of Hodgkin lymphoma; currently the only immunotoxin in the U.S. market
Centruroides (Scorpion) Immune F(ab)2 (Equine) Injection [Anascorp] granted on 8/3/2011 to Rare Disease Therapeutics Inc. for treatment of scorpion stings, with manufacture by Instituto Bioclon, S.A. (Mexico) [Is this the first Latin American-manufactured complex biologic to receive full BLA approval?]
Fibroblasts, autologous [azfibrocel-T - laViv; Isolagen Therapy] granted on 6/22/2011 to Fibrocell Science, Inc. for treatment of the appearance of nasolabial fold wrinkles (smile lines)
CTLA4-Ig, rDNA [belatacept - Nulojix; BMS-224818; CTLA4-Ig mutant; cytotoxic T-lymphocyte- associated antigen 4 (CTLA-4)--Immunoglobulin G1 fragment fusion protein, recombinant] granted on 6/15/2011 to Bristol-Myers Squibb (BMS) for prevention of acute rejection in adult kidney transplant patients
Albumin, human - [Kedbumin] granted on 6/3/2011 to Kedrion, S.p.A. for treatment of hypovolemic shock, hypoalbuminemia, prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), burns, hemodialysis patients undergoing long term dialysis, patients who cannot tolerate substantial volumes of salt solution and as a priming solution for cardiopulmonary bypass
CTLA-4 Mab, rDNA/Medarex [Yervoy; Ipilimumab; MDX-010; cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody, recombinant] granted on 3/25/2011 to Bristol-Myers Squibb (BMS) for treatment of late-stage melanoma
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral [composed of Adenovirus Vaccine, type 4 and Adenovirus Vaccine, type 7] granted on 3/16/2011 to Teva Pharmaceuticals for immunization of U.S. military personnel only
B-cell-activating factor Mab, rDNA: [belimumab - Benlysta; LymphoStat-B] granted on 3/9/2011 to Human Genome Sciences, Inc. (for marketing along with GlaxoSmithKline/GSK) for treatment of treatment of adults with active, autoantibody-positive systemic lupus erythematosus
Factor XIII, human: [Cortifact] granted on 2/17/2011 to CSL Behring for treatment of Factor XIII deficiency

2010

Urate oxidase, rDNA, PEG-: [Pegloticase - Krystexxa; Puricase; PEG-uricase; pig-baboon uric acid oxidase, recombinant, pegylated] granted on 9/14/2010 to Savient Pharmaceuticals for treatment of chronic refractory gout.
Botulinum Toxin A/Merz: [Xeomin; Clostridium botulinum toxin type A; NT 201] granted on 7/30/2010 to Merz Pharmaceuticals for treatment of adults with cervical dystonia or blepharospasm.
Antitrypsin, alpha-1/Kamada: [alpha-1-Proteinase Inhibitor (Human) - Glassia; Respira; alpha-1 antitrypsin; AAT; A1P1] granted on 7/1/2010 to Kamada Ltd. for treatment of alpha1-antitrypsin deficiency.
RANKL Mab, rDNA: [Denosumab - Prolia; AMG 531; AMG 162. receptor activator of nuclear factor kappa B ligand (RANKL) monoclonal antibody, recombinant] granted on 6/1/2010 to Amgen Inc. for treatment of postmenopausal women with osteoporosis at high risk for fracture
Glucosidase, rDNA/Lumizyme: [Alglucosidase alfa - Lumizyme; alpha glucosidase; glucosidase alpha; rhGAA]] granted on 5/25/2010 to Genzyme Corp. for treatment of Pompe disease
Prostate Cancer Cellular Vaccine (rDNA): [Sipuleucel-T - Provenge - prostatic acid phosphatase (PAP)--granulocyte macrophage-colony stimulating factor (GM-CSF) recombinant fusion protein (PAP-GM-CSF; PA2024)-sensitized autologous antigen-presenting cells (APCs); PA2024-loaded APCs; APC8015] granted on 4/29/2010 to Dendreon Corp. for treatment of asymptomatic or minimally symptomatic metastatic prostate cancer resistant to standard hormone treatment
Pancreatic Enzymes/J&J: [Pancreaze; Pancreatic Enzyme Product] NDA granted on 4/12/2010 to Johnson & Johnson (J&J) for treatment of pancreatic insufficiency
Fibrin Sealant/TachoSil [Absorbable Fibrin Sealant Patch] granted on 4/2/20101 to Nycomed Austria GmbH for use as an adjunct to hemostasis in cardiovascular surgery when control of bleeding by standard surgical techniques, such as suture, ligature or cautery, is ineffective or impractical.
Immune globulin (SCIG) [Immune Globulin Subcutaneous (Human) - Hizentra; (Vivaglobin is an older, lower-concentration product)] granted on 3/4/2010 to CSL Behring for treatment of primary immunodeficiency
Glucocerebrosidase, rDNA/Shire [velaglucerase alfa; ceramidase, glucosyl-(human HT-1080 cell); human glucosylceramidase (EC 3.2.1.45 or beta-glucocerebrosidase), glycoform alpha; beta-glucocerebrosidase] granted on 2/26/2010 to Shire Pharmaceutical for treatment of Gaucher Disease
Pneumococcal Vaccine(13)-CRM197 [Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) - Prevnar 13; Prevenar 13; Streptococcus pnuemoniae capsular antigen-Diphtheria CRM197 protein conjugate vaccine; PCV13] granted on 2/24/2010 to Pfizer (developed by Wyeth) for prevention of Streptococcus pnuemoniae-related disease
Meningococcal Conjugates Vaccine/Novartis [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Menveo; MenACWY-CRM] granted on 2/19/2010 to Novartis prophylaxis against invasive meningococcal disease
Collagenase [clostridial collagenase for injection - Xiaflex] granted on 2/3/2010 to Auxilium Pharmaceuticals Inc. for the treatment of treatment of Dupuytren's disease
Glucagon-like peptide-1, rDNA [liraglutide - Victoza; Arg34-GLP-1[7-37]; GLP-1 [recombinant]; NN-2211] granted on 1/25/2010 to Novo Nordisk for the treatment of type 2 diabetes
Interleukin-6 receptor Mab, rDNA [tocilizumab; Actemra; RoActemra; interleukin-6 receptor monoclonal antibody, recombinant; IL-6r Mab] granted on 1/8/2010 to Amgen for the treatment of rheumatoid arthritis (RA)

2009

Influenza Vaccine, high dose [Fluzone High-Dose] granted on 12/23/2009 to Sanofi Pasteur for the the prevention of influenza in persons 65 years of age of older; full BLA granted, but this is simply a higher-dose (60 µg vs. 15 µg of each influenza strain HA antigen) formulation of Fluzone, the influenza vaccine most used in the U.S.; [Should this be considered a new product or not? You decide. It's the same old product, at a different concentration, but with a new full approval and a new but much the same indications with these a subset of those approved for use of regular Fluzone].

vWF/Factor VIII Complex [Wilate] granted on 12/4/2009 to Octapharma USA, Inc. for the treatment of von Willebrand disease (VWD)

Kallikrein inhibitor, rDNA [ecallantide - Kalbitor; DX-88; kallikrein inhibitor protein, recombinant] granted on 12/1/2009 to Dyax Corp. for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older

Influenza vaccine/Novartis Italy [Agriflu] granted on 11/27/2009 to Novartis for prophylaxis against H1N1 (swine flu) influenza; This (or much the same) conventional inactivated egg-cultured vaccine has long been manufactured at site in Siena, Italy, primarily for European markets.

Influenza vaccine, H1N1/GSK Canada granted on 11/10/2009 to ID Biomedical, subsidiary of GlaxoSmithKline (GSK), for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA. [This is an H1N1 analog or biosimilar/biogeneric monovalent version of Influenza vaccine/GSK Canada (FluLaval)].

CD20 Mab, human, rDNA [ofatumumab - Arzerra; HuMax-CD20; CD20 monoclonal antibody, human, recombinant] granted on 10/26/2009 to GlaxoSmithKline (and Genmab) for the treatment for chronic lymphocytic leukaemia in patients who have not responded to Campath (alemtuzumab) or fludarabine

Antitrypsin, alpha-1/Talecris [Alpha-1-Proteinase Inhibitor (Human) - Prolastin-C; alpha1-antitrypsin] granted on 10/19/2009 to Talecris Biotherapeutics for the treatment of alpha1-antitrypsin (AAT) deficiency

HPV vaccine, rDNA/GSK [Cervarix MEDI 501; human papilloma virus (HPV) vaccine types 16 and 18 L1 virus-like particles, recombinant] granted on 10/16/2009 to GlaxoSmithKline, Inc. for prophylaxis against cervical cancer in females

C1-esterase inhibitor/CSL [Berinert P; C1INH; C1-INH; complement C1 esterase inhibitor, plasma-derived] granted on 10/09/2009 to CSL Behring LLC for the acute treatment of hereditary angioedema (HAE)

IL-12/23 p40 Mab, rDNA [ustekinumab - STELARA; CNTO 1275; interleukin-12 (IL-12) and interleukin-23 (IL-23) p40 subunit monoclonal antibody, human, recombinant] granted on 9/25/2009 to Centocor Ortho Biotech Inc. (Johnson & Johnson) for treatment of moderate to severe plaque psoriasis

Immune Globulin (IGIV)/Bio Products [Immune Globulin Intravenous (Human) - Gammaplex] granted on 9/17/2009 to Bio Products Lab. for the treatment of primary humoral immunodeficiency

Influenza vaccine, H1N1/Novartis granted on 9/15/2009 to Novartis AG for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Influenza vaccine, H1N1/Sanofi granted on 9/15/2009 to Sanofi-Pasteur for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Influenza vaccine, H1N1/CSL granted on 9/15/2009 to CSL Ltd. for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Influenza Vaccine, live rDNA, H1N1 granted on 9/15/2009 to MedImmune (AstraZeneca) for prophylaxis against H1N1 (swine flu) influenza; Note, although a new and distinct product, this was approved as a supplemental BLA

Haemophilus b Vaccine/GSK [Hiberix; Haemophilus influenzae Type b vaccine; Hib vaccine] granted on 8/19/2009 to GlaxoSmithKline (GSK) as Hib vaccine booster dose for children 15 months through 4 years old

Interferon betaser, rDNA/Novartis [Interferon beta-1b - Extavia; 2-166-Interferon beta1 (human fibroblast reduced), 17-L-serine-; interferon betaser, recombinant; NVF233] granted on 8/15/2009 to Novartis Pharmaceuticals for multiple sclerosis indications
Note, this is simply a rebranded (relabeled) version of Betaseron from Bayer Schering. Thus, although the product received a full BLA approval, it is not a new product from an entity/composition perspective - only from strict (or contrived) approval- and commercial/sales-based perspectives. Does this product deserve 12 years of biosimilar data exclusivity? Following current legislation, which grants products exclusivity based on receiving BLA approval, this product, which is simply a relabeled version of another (an "authorized generic"), would receive exclusivlty. See www.biosimilarspipeline.com for further discussion of this and other aspects of biosimilars legislation].

Interleukin-1 Mab, rDNA [Canakinumab - Ilaris; interleukin-1 beta monoclonal antibody; ACZ885] granted on 6/17/2009 to Novartis Pharmaceuticals for treatment of Cryopyrin Associated Periodic Syndrome (CAPS)

Pancreatic Enzyme/Solvay [pancrelipase - Creon; pancreatic enzymes, porcine-derived] granted on 5/1/2009 to Solvay for treatment of exocrine pancreatic enzyme insufficiency [Note, although this is Creon's first approval, this is not a new product. This same product has long been grandfathered -- on the market for so many decades that it had never been previously required to receive formal approval].

Botulinum Toxin A/Ipsen [abobotulinumtoxinA - Dysport; Reloxin; Clostridium botulinum toxin type A] BLA granted on 4/29/2009 to Ipsen for treatment of cervical dystonia and a sBLA granted at the same time to Medicis for Reloxin (relabeled Dysport) for treatment of gabellar (frown) lines.

TNF Mab, rDNA, human/J&J [Simponi; golimumab; CNTO 148; tumor necrosis factor-alpha human monoclonal antibody, recombinant] granted to Centocor Ortho Biotech Inc./Johnson & Johnson on April 24, 2009 for treatment of three types of immune dysfunction-related arthritis

Japanese Encephalitis Vaccine/Intercell - [Ixiaro; Japanese encephalitis SA14-4-2 virus vaccine; IC51] granted to Intercell Biomedical (with marketing by Novartis) on 3/30/2009 for prevention of Japanese encephalitis disease

Antithrombin III, rDNA [Antithrombin III (Human) - ATryn; rhATIII; AT-III, recombinant transgenic goat] granted to GTC Biotherapeutics, Inc. (Genzyme) on 2/6/2009 for prevention of blood clots in patients with antithrombin deficiency
Fibrinogen/CSL [Fibrinogen Concentrate (Human) - RiaSTAT; Haemocomplettan P; Factor I] granted on 1/16/2009 to CSL Behring for treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia).

2008 [Note, 3 of the 13 products listed below that received full approvals (BLA or NDA) in 2008 involve simple combination use and/or packaging of previously approved products, and are not considered by BIOPHARMA to be new, distinct/unique products. This is further discussed in the 2008 approvals analysis update. Another product, Xyntha, fallls in a grey area (is unclear whether it should be considered an updated version or a new product)]:

C1-esterase inhibitor/Sanquin [Cinryze; CetorA; C1INH; C1-INH; complement C1 esterase inhibitor, plasma-derived] granted on 10/10/2008 to Lev Pharmaceuticals for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE; C1 inhibitor deficiency)

Insulin aspart, rDNA, 50/50 mix [Novolog Mix 50/50; Biophasic Insulin Aspart 50/50] granted on 8/26/2008 to Novo Nordisk for treatment of diabetes [A simple 50/50 mixture of previously-approved Novolog (insulin aspart, rDNA) and regular recombinant insulin, despite receiving a full NDA, BIOPHARMA does not consider this to be a new/novel product. If this were considered as a distinct/unique product, every other combination of insulin variants would need to similarly be treated as a different, unique/distinct product].

Thrombopoietin peptibody, rDNA [romiplostim - NPLATE; AMG-531; Amgen Megakaryopoiesis Protein 531; thrombopoietin mimetic peptibody, recombinant] granted on 8/22/2008 to Amgen for treatment of adults with chronic immune thrombocytopenic purpura (ITP)

DTaP-Hib-Polio Vaccine/Sanofi [Pentacel; ActHIB Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated; ActHIB plus Quadracel; Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Haemophilus influenzae type b (Hib) vaccine plus Poliovirus Vaccine Inactivated (Human Diploid Cell)] granted on 6/20/2008 to Sanofi Pasteur [As the combination of two previously approved combination vaccines, with the two mixed before administration, BIOPHARMA does not consider this to be a new, distinct/unique product].

Interferon alfa-2b, rDNA, PEG- plus Ribavirin [PEGPAK; combination packaging of PEG-Intron and ribavirin] granted 6/13/2008 to Schering-Plough for treatment of chronic hepatitis C [As simple combined packaging and use of already-approved PEG-Intron and the drug, ribavirin, with this combination long in therapeutic use, BIOPHARMA does not consider this to be a new, distinct/unique product].

TNF Mab Fab', rDNA, PEG- [Certolizumab pegol - Cimzia; CDP 870; tumor necrosis factor monoclonal antibody Fab fragment, recombinant--polyethylene glycol (PEG) polymer conjugate] granted on 4/23/2008 to UCB (with U.S. marketing by Bayer Schering) for treatment of refractory Crohn's disease in adults

Rotavirus Vaccine, live/GSK [Rotavirus Vaccine, Live, Oral, Monovalent - Rotarix; RIX-4414] granted on 4/4/2008 to GlaxoSmithKline (GSK) for prevention of rotavirus gastroenteritis in infants

DTaP-IPV/GSK [Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Poliovirus Vaccine Inactivated (Human Diploid Cell) - Kinrix] granted on 3/24/2008 to GlaxoSmithKline for pediatric vaccination

Fibrin Sealant/Baxter [Fibrin Sealant, VH S/D 4 - Artiss; Fibrin Sealant, Vapor Heated Solvent/Detergent Treated] granted on 3/19/2008 to Baxter Healthcare for use in attaching skin grafts onto burn patients. [This appears to be a next-generation version and replacement for Tisseel Kit VH].

Interleukin-1 trap, rDNA [Arcalyst; rilonacept; IL-1 Trap, recombinant] granted on 2/27/2008 to Regeneron Pharmaceuticals Inc. for long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Antihemophilic Factor (Recombinant), Plasma/Albumin Free [Xyntha; recombinant coagulation factor VIII; an updated version of ReFacto, now with no human or animal products used in its manufacture or formulation]; full BLA granted to Wyeth on 2/21/2008 for treatment of hemophilia A
Is this a new product or not? It all depends on how you view biopharmaceutical similarity/uniqueness/sameness and approvals. See "What is a Generic Biopharmaceutical?" and "What is a Biopharmaceutical?" and other articles at biopharmacopeia.com and biosimilarspipeline.com. With its seemingly minimal trials (abbreviated filing), similar (but different) formulation and manufacturing process and its active agent being confirmed by FDA as the same/identical rDNA human Factor VIII as in ReFacto, which this product is replacing, Xyntha exhibits many aspects of being a follow-on (biosimilar) version of ReFacto. Xyntha could also be considered the same product (not a new product), just a minor variation or new version of ReFacto, with such approvals typically (for decades) handled as supplemental approvals. Some, primarily considering that Xyntha's manufacturing processes and formulation have been changed substantially (updated to state-of-the-art), would consider this a fully new/novel/distinct product (and one fully worthy of receiving full-length data exclusivity protection from use as a reference product for biosimilar approval). [With BLAs proposed as the determinant for granting 12-14 years exclusivity to refernce (innovator) biologics, there is a major potential advantage to getting full vs. supplemental approvals wherever possible]. FDA accepts the drug substance (B-domain-deleted recombinant Factor VIII protein) in the two products to be the same (unchanged). But with no bioequivalence or other direct comparison clinical studies [and with both products' BLA approvals based on showing comparability with a full-lengh Factor VIII product], there is at best indirect demonstration of Xyntha being clinically comparable, substitutable or interchangable with ReFacto (although most physicians, pharmacists, patients, etc. will simply transition from ReFacto to Xyntha and consider them much the same). Others may ignore any consideration of the active agents and products and consider Xyntha a new/novel/unique product based solely on it having received full vs. supplemental BLA approval (although approvals/BLAs were never designed to define new products). Further confounding the situation, the product marketed as Xyntha in the U.S. received full, not supplemental, approval in the European Union under the trade name Refacto AF [animal-free], clearly presenting it as the same as the prior ReFacto, just a new variation or version, and indicative of full comparability, substitutablity and interchangability.
[Is Xyntha a new product -- a new reference product for purposes of considering biosimilars/follow-on applications -- or not? If eventual U.S. biosimilars legislation grants years of data exclusivity to new reference products, should Xyntha receive this protection or not? These are very good questions, and such issues, including related opportunities for infinite evergreening, appear not to be seriously addressed in ongoing discussions of biosimilar's legislation].

Somatropin, rDNA/Cangene [Somatropin (rDNA origin) for Injection - Accretropin] - 505(b)(2) follow-on protein NDA granted on 1/24/2008 to Cangene Corp. (marketing by Apotex) for treatment of pediatric growth failure or short stature

Thrombin, rDNA [Recothrom; Thrombin, recombinant; rhThrombin] - granted on 1/17/08 to ZymoGenetics, Inc. to help halt bleeding from small blood vessels after surgery

2007:

EPO, rDNA, PEG- [Continuous Erythropoietin Receptor Activator; Mircera; CERA; epoetin alpha (recombinant), pegylated; methoxy polyethylene glycol-epoetin beta)] - granted on 11/14/07 to Hoffmann-La Roche Inc. for treatment of anemia associated with chronic renal failure in adults [Note, product may never be launched in U.S. due to infringement of patents held by Amgen (related lawsuit nearly but not yet finally resolved)].

Skin, Cultured/Epicel [Cultured Epidermal Autograft - Epicel; Cultured Autologous Keratinocytes Service; CEA] - HDE granted on 10/29/07 to Genzyme Corp. for the treatment of life-threatening wounds resulting from severe burns.

Influenza Vaccine/CSL [Influenza Virus Vaccine, Trivalent, Types A and B - AFLURIA; Fluvax; Enzira] - granted on 9/28/07 to CSL Ltd. for prophylaxis against influenza.

Smallpox vaccine/Vero - granted on 8/31/07 to Acambis plc for prophylaxis against smallpox (in the biodefense stockpile).

Thrombin/Omrix [Evithrom] - granted on 8/27/2007 to Omrix Biopharmaceuticals for control of bleeding (inaccessible/otherwise untreatable oozing of blood and minor bleeding from capillaries and small venules)

Fibrin Sealant/Thermogenesis [CryoSeal Fibrin Sealant System; CryoSeal FS System; cryoprecipitate plus thrombin, autologous]; granted on 7/26/2007 to Thermogenesis Corp. for control of bleeding during liver surgery

Immune Globulin (IGIV), liquid/CSL [Immune Globulin Intravenous (Human), 10% Liquid - Privigen]; granted on 7/26/2007 to CSL BioPlasma Inc. for treatment of primary immunodeficiency

Influenza Vaccine, H5N1/Sanofi [Influenza Virus Vaccine, H5N1; pandemic influenza vaccine; bird flu vaccine]; granted on 4/17/2007 to Sanofi Pasteur Inc. for active immunization of adults at increased risk of exposure to the H5N1 influenza virus [for use in case of a bird flu-related influenza epidemic/pandemic]

Somatropin, rDNA/BioPartners [Somatropin (rDNA origin) for Injection - Valtropin; human growth hormone, recombinant]; granted on 4/19/2008 to Parexel, a CRO proxy for LG Life Sciences, for treatment of growth deficiencies [Incredibly, despite this being a follow-on protein, generic drug approval, not a single news report has yet to came out about this, other than Signals magazine in fall 2007)! This author noticed Valtropin's approval in mid-March 2008, so it did not make it into the approvals review. Apparently, FDA neglected to announce this approval through normal channels at the time. Was this as "stealth" follow-on protein approval?].

Protein C, plasma-derived [Ceprotin]; granted on 3/27/2007 to Baxter Healthcare for treatment of severe congenital Protein C deficiency.

Complement C5 Mab, rDNA [Eculizumab - Soliris; complement C5 monoclonal antibody, recombinant] - granted on 3/16/07 to Alexion Pharmaceuticals, Inc. for ttreatment of paroxysmal nocturnal hemoglobinuria (PNH)

Poly-4-hydroxybutyrate, rDNA [TephaFLEX Absorbable Suture; poly-4-hydroxybutyrate; P4HB; poly(4HB); PHA4400] - granted on 2/12/2007 to Tepha, Inc. for use as surgical sutures

2006:

Albumin (Human) [one of many Albumin products] - granted on 10/17/06 to Octapharma Pharmazeutika Produktionsgesm.b.H for the restoration and maintenance of circulating blood volume

Influenza vaccine/ID Biomedical [Influenza Virus Vaccine, Trivalent - FluLaval; Fluviral] granted on 10/05/06 to GlaxoSmithKline (acquired ID Biomedical) for the active immunization of adults 18 years and older against influenza.

EGF receptor Mab, human, rDNA [Panitumumab - Vectibix; ABX-EGF; epidermal growth factor receptor monoclonal antibody, human, recombinant; E7.6.3; rHuMAb-EGFr; transgenic XenoMouse-derived human EGF receptor Mab]; granted on 9/27/2006 to Amgen Inc. "for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens"

Iduronate-2-sulfatase, rDNA [Idursulfase; Elaprase; L-iduronate 2-sulfate sulfatase precursor; recombinant; I2S; chondroitinsulfatase]; granted on 7/24/2006 to Shire Pharmaceuticals Group plc (through its acquisition of Transkaryotic Therapies, Inc.) for the treatment of Hunter syndrome (mucopolysaccharidosis II; MPS II).

VEGF Mab Fab, rDNA [Lucentis; vascular endothelial growth factor monoclonal antibody fragment, recombinant] granted on 6/30/2006 to Genentech, Inc. for treatment of age-related macular degeneration

HPV vaccine, rDNA/Merck [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine;- Gardasil; human papilloma virus (HPV) types 6, 11, 16 and 18 L1 virus-like proteins (VLPs), recombinant]; granted on 6/8/2006 to Merck & Co., Inc. for vaccination in females 9-26 years of age for prevention of diseases caused by human papillomavirus (HPV) types 6, 11, 16, and 18.

Somatropin, rDNA/Sandoz [Somatropin (rDNA origin) - Omnitrope; human growth hormone, recombinant] granted on 5/30/2006 to Sandoz, Inc., a subsidiary of Novartis AG, for treatment of growth hormone deficiency.

Varicella Virus Vaccine/adult [Zoster vaccine live (Oka/Merck); Zostavax; Varicella virus vaccine for adults]; granted on 5/25/2006 to Merck & Co., Inc. for prevention of herpes zoster (shingles) in persons 60 years of age or older.

Glucosidase, rDNA [Alglucosidase alfa - Myozyme; Pompase; alpha glucosidase; glucosidase alpha (rhGAA) [recombinant]]; granted on 4/28/2006 to Genzyme Corp. for treatment of Pompe disease.

Rotavirus Vaccine, rDNA/Merck [Rotavirus Vaccine, Quintavalent - RotaTeq; WC3 pentavalent vaccine]; granted on 2/3/2006 to Merck & Co., Inc. for prevention of pediatric rotavirus gastrointestinal disease.

Hepatitis B Immune Globulin, i.m./Cangene [Hepatitis B Immune Globulin (Human); HepaGam B]; granted on 1/27/2006 to Cangene Corp. for for post-exposure propylaxis following acute exposure to hepatitis B virus.

Insulin, rDNA, inhaled/Pfizer [Exubera Insulin, recombinant powder for inhalation]; granted on 1/27/2006 to Pfizer, Inc. for the treatment of adults with type 1 and type 2 diabetes.

Immune globulin (SCIG) [Vivaglobin]; granted on 1/9/2006 to ZLB Behring for treatment of primary immunodeficiency.

2005

CTLA4-Ig, rDNA [Orencia; Abatacept; cytotoxic T-lymphocyte- associated antigen 4--Immunoglobulin G1 fragment fusion protein, recombinant; BMS-188667] granted on 12/26/2005 to Bristol-Myers Squibb Co. for second-line treatment of rheumatoid arthritis in moderate to severe adult patients.

Insulin-like Growth Factor-1/IGFBP-3, rDNA [Mecasermin rinfibate - IPLEX; SomatoKine; nsulin-like growth factor I--insulin-like growth factor-binding-3 protein complex, recombinant; IGF-1/IGFBP3 complex] granted on 12/12/2005 to Insmed Inc. for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Hyaluronidase, rDNA [Hylenex; Enhanze SC; Cumulase; Chemophase; rHuPH20; PH-20 hyaluronidase, recombinant human] approval of Hyelex (formerly Enhanze SC) granted on 12/5/2005 to Halozyme Therapeutics Inc. for marketing by Baxter for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (hypodermoclysis).

Hyaluronidase, ovine/Primapharm [Hydase] granted on 10/25/2005 to PrimaPharm, Inc. for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (hypodermoclysis).

PDGF, rDNA/Bone matrix [Platelet-derived growth factor (PDGF)-BB, recombinant with inorganic bone matrix; rhPDGF-BB; GEM 21S] granted on 10/21/2005 to BioMimetic Therapeutics, Inc. for marketing by Osteohealth Co. (Luitpold Pharmaceuticals, Inc., Sankyo Co., Ltd.) for the treatment of periodontal bone defects and associated gingival recession.

Measles Mumps Rubella & Varicella Vaccine [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live - ProQuad; M-M-R II plus Varivax vaccine] granted on 9/6/2005 to Merck & Co., Inc. for vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age

Influenza Vaccine/GSK Canada [Influenza Virus Vaccine, Trivalent, Types A and B - Fluarix]; granted on 8/31/2005 to GlaxoSmithKline Biologicals for prevention of influenza

Influenza vaccine/GSK Germany [Influenza Virus Vaccine, Trivalent - Fluarix; Influsplit SSW; Alpharix]; granted on 8/31/2005 to Sachsische Serumwerke AG for marketing by GlaxoSmithKline for prevention of influenza.

Insulin-like Growth Factor-1, rDNA/Tercica [Insulin-like Growth Factor-1, recombinant - Increlex; IGF-1] granted on 8/31/2005 to Tercica, Inc. (partnered with Genentech) for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone

Calcitonin, rDNA [Calcitonin (salmon) - Fortical; calcitonin, recombinant] granted on 8/15/2005 to Unigene, Inc. (marketed by Upsher-Smith Labs.) for the treatment of postmenopausal osteoporosis

Insulin detemir, rDNA - [Insulin detemir, recombinant - Levemir] granted on 6/17/2005 to Novo Nordisk Inc. for the treatment of diabetes mellitus (type 1 and type 2; [a long-acting recombinant insulin analog]

dTpa booster/Sanofi [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Adacel; dTpa; Tdap] granted on 6/10/2005 to Aventis Pasteur Ltd. for use as a tetanus, diptheria and pertussis (whooping cough) booster vaccine for those ages 11-64

Arylsulfatase B, rDNA [N-acetylgalactosamine 4-sulfatase - Naglazyme; Aryplase; galsulfase; chondroitinase; rhASB (recombinant)] - granted on 5/31/2005 to BioMarin Pharmaceutical Inc. for treatment of mucopolysaccharidosis VI (MPS VI).

dTpa booster/GSK [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Boostrix; dTpa; Tdap] - granted on 5/3/2005 to GlaxoSmithKline Biologicals S.A. for use as a tetanus, diptheria and pertussis (whooping cough) booster vaccine for those ages 10-18

Tetanus Toxoid/Chiron [Tetanus Toxoid Concentrate (For Further Manufacturing Use]; granted on 5/3/2005 to Chiron Behring GmbH & Co. (Chiron Corp.; merging into Novartis AG) for use as a component of Boostrix combination vaccine (see above entry)

Vaccinia Immune Globulin, i.v./Cangene [VIG; VIVIG] - granted on 5/3/2005 to Cangene Corp. for treatment of rare complications of smallpox vaccination (systemic, severe skin or other serious infections due to the live vaccinia virus in current smallpox vaccines)

Hyaluronidase, rDNA [Cumulase; Enhanze SC; Chemophase; rHuPH20; PH-20 hyaluronidase, recombinant human] - device approval of Cumulase on 4/19/2005; granted to Halozyme Therapeutics, Inc. for use in in vitro fertilization (IVF) procedures (preparation of oocytes prior to in vitro fertilization)

Vaccinia Immune Globulin, i.v./DVC [VIG; VIGIV] - granted on 2/18/2005 to DynPort Vaccine Co. LLC for treatment of rare complications of smallpox vaccination (systemic, severe skin or other serious infections due to the live vaccinia virus in current smallpox vaccines)

Thrombin, conc. [Thrombin (Human) (For Further Manufacturing Use)] - granted on 2/18/2005 to Baxter Healthcare Corp. for further manufacture of FloSeal Matrix Hemostatic Sealant, used to control bleeding

Meningococcal Conjugates Vaccine [Menactra; Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; MCV-4] - granted on 1/14/2005 to Sanofi Pasteur Inc. for protection against meningococcal disease in adolescents and adults aged 11-55 years

2004:

VEGF apatamer, PEG - [Pegaptanib sodium - Macugen; vascular endothelial growth factor/vascular permeability factor (VEGF) aptamer, synthetic oligonucleotide, PEGylated)] granted on 12/17/2004 to Eyetech Pharmaceuticals, Inc. for treatment of neovascular (wet) age-related macular degeneration [synthetic 28-mer oligonucleotide, mimics a VEGF antibody; not a biopharmaceutical].

Keratinocyte growth factor, rDNA* [Palifermin - Kepivance; des1-23 KGF; 24-163 fibroblast growth factor 7 (human)] granted on 12/15/2004 to Amgen Inc. for treatment of severe oral mucositis (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, followed by a bone marrow transplant.

Integrin Mab, rDNA [Tysabri - natalizumab; Antegren; integrin alpha(4) humanized monoclonal antibody] granted on 11/24/2004 to Biogen Idec for treatment of multiple sclerosis [formerly Antegren (trade name), now Tysabri; changed at FDA request].

Hyaluronidase, bovine/Amphastar - [Hyaluronidase, bovine - Amphadase] granted on 10/24/2004 to Amphastar Pharmaceuticals, Inc. for use as a "spreading agent," e.g., as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] full approval (upgraded from accelerated approval granted 3/2003) granted on 10/15/2004 to Hoffmann-La Roche Inc. for the treatment of HIV-1 infection in in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy [synthetic peptide, not a biopharmaceutical].

CD15 Mab-Tc 99m radioconj. [Technetium (99m Tc) fanolesomab; Neutrospec; Leutech; TC99M-labeled CD15 monoclonal antibody] - granted on 7/2/2004 to Palatin Technologies, Inc. for diagnostic imaging of appendicitis (scintigraphic imaging of patients with equivocal signs of appendicitis who are five years of age or older.)

Luteinizing hormone, rDNA [Lutropin alfa - Luveris; human luteinizing hormone, recombinant] granted to Serono, Inc. on 5/24/204 for infertility treatment [stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency in combination with FSH (Gonal-f)].

Immune Globulin (IGIV)/Octapharma [Octagam; Immune Globulin Intravenous (Human)] - granted on 5/21/2004 to Octapharma AG for treatment of primary immune deficiency.

Hyaluronidase, ovine [Vitrase; hyaluronate 4-glycanohydrolase] granted on 5/4/2004 to ISTA Pharmaceuticals Inc. for use as a spreading agent to facilitate the dispersion and absorption of drugs, particularly local anesthetics, during ophthalmic surgery; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents

Insulin glulisine, rDNA [Apidra; [LysB3, GluB29] insulin; insulin (human), 3B-l-lysine, 29B-l-glutamic acid-, recombinant] - granted on 4/16/2004 to Aventis Pharma for use as a rapid-acting insulin for treatment of diabetes.

VEGF Mab, rDNA [Avastin; bevacizumab; vascular endothelial growth factor monoclonal antibody, recombinant] - granted on 2/26/2004 to Genentech, Inc. for use in combination with 5-fluorouracil for treatment of metastatic cancer of the colon or rectum.

EGF receptor Mab, rDNA [Cetuximab - Erbitux; IMC-C225; epidermal growth factor receptor monoclonal antibody, recombinant] - granted on 2/12/2004 to ImClone Systems Inc. (for marketing by Bristol-Myers Squibb Co.) for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy, and for monotherapy treatment of patients with EGFR-expressing metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.

Rho(D) Immune Globulin/ZLB [Rho(D) Immune Globulin Intravenous (Human) - Rhophylac] - granted on 2/12/2004 to ZLB Bioplasma AG for antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women.

Hyaluronic acid/Anika [ORTHOVISC High Molecular Weight Hyaluronan] - granted on 2/5/2004 to Anika Therapeutics, Inc. for U.S. marketing by Ortho Biotech Products, L.P. (Johnson & Johnson) for the treatment of pain associated with osteoarthritis of the knee. [Derived from rooster combs; considered a borderline biopharmaceutical product]

2003:

Immune Globulin Intravenous (Human) [Flebogamma] - granted on 12/18/2003 to Instituto Grifols (Probitas Pharma) for treatment of primary immune deficiency.

Hyaluronic acid/Medicis [Restylane] - granted on 12/12/2003 to Medicis Pharmaceutical Corp. for correction of moderate to severe facial wrinkles and folds, e.g., nasolabial folds (lines/folds near the nose and mouth). [bacterial fermentation-derived; considered a mainstream biopharmaceutical product]

CD11a Mab, rDNA [Efalizumab - Raptiva; CD11a monoclonal antibody, recombinant] - granted on 10/27/2003 to Genentech, Inc. and Xoma Ltd. for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic or phototherapy.

Botulism Immune Globulin Intravenous (Human) [BabyBIG] - granted on 10/23/2003 to the California Department of Health Services for treatment of infant botulism caused by type A or type B Clostridium botulinum.

Somatropin, rDNA/Serono [Somatropin (rDNA origin) - Serostim; human growth hormone, recombinant] - full approval granted on 8/29/2003 to Serono Inc. for the treatment of HIV patients with wasting or cachexia [upgraded from accelerated approval granted in 1996]

Factor VIII, rDNA, PFM [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method - Advate; Factor VIII, recombinant; rAHF-PFM] - granted on 7/25/2003 to Baxter Hyland Immuno for treatment of hemophilia A.

TNF Receptor-IgG Fc, rDNA [Etanercept - Enbrel; tumor necrosis factor receptor2-immune globlulin G1 Fc fusion protein, recombinant] - supplemental BLA granted on 7/24/2003 to Amgen Inc. for treatment of active ankylosing spondylitis.

Antitrypsin, alpha-1/Aventis [Alpha-1-Proteinase Inhibitor (Human) - Zemaira] - granted on 7/8/2003 to Aventis Behring LLC for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor deficiency and evidence of emphysema.

CD20 Mab, rDNA--I 131 radioconj. [Iodine I 131 tositumomab - Bexxar; CD20 monoclonal antibody--Iodine I 131 radioimmune conjugate] - granted on 6/27/2003 to Corixa Corp g . (formerly Coulter Pharmaceutical) with marketing by GlaxoSmithKline (GSK) for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma (NHL), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.

Immunoglobulin E Mab, rDNA [Omalizumab - Xolair; rhuMab-E25; immunoglobulin E25 monoclonal antibody, recombinant; IgE Mab, rDNA] - granted on 6/20/2003 to Genentech, Inc. (with manufacture by Tanox, Inc. and co-marketing by Novartis Pharmaceutical Corp.) for treatment of moderate-to-severe allergic asthma.

Hirudin, desulfato- rDNA/Aventis [Iprivask; Desirudin; Revasc; desulfatohirudin; hirudin, desulfato- recombinant] - granted on 4/3/2003 to Aventis Pharma for approved for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.

Influenza Vaccine, live rDNA, frozen [FluMist] - granted on 6/17/2003 to MedImmune Vaccines, Inc. (subsidiary of MedImmune, Inc.) for influenza prophylaxis in healthy persons from 5-50 year of age.

Iduronidase, rDNA [laronidase; Aldurazyme; alpha-L-iduronidase] - granted on 4/30/2003 to Biomarin Pharmaceutical Inc. (and Genyzme Corp.) for treatment of Mucopolysaccharidosis I (MPS I)

Galactosidase, beta rDNA [Agalsidase beta - Fabrazyme; alpha-galactosidase A] - granted on 4/24/2003 to Genzyme Corp. for treatment of Fabry disease

Somatropin antagonist, PEG-, rDNA [Pegvisomant - Somavert; somatropin antagonist, pegylated, recombinant] - granted on 3/25/2003 to Pharmacia Corp. for treatment of acromegaly

Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] - granted on 3/15/2003 to Hoffmann-La Roche Inc. for treatment of HIV-infection [synthetic; not a biopharmaceutical]

LFA-3/IgG1, rDNA [Alefacept; Amevive; leukocyte function-associated antigen-3/immune globulin G (IgG) fusion protein, recombinant] - granted on 1/30/2003 to Biogen Corp. for treatment of moderate-to-severe chronic plaque psoriasis

Antitrypsin, alpha-1/Baxter [alpha-1 Proteinase Inhibitor (Human); Aralast; alpha-1 antitrypsin; AAT; A1P1] - granted on 1/9/2003 to Alpha Therapeutic Corp. (for marketing by Baxter) for enzyme replacement therapy in patients with heredity emphysema (AAT deficiency)

2002:

TNF Mab, rDNA, human [Adalimumab; Humira; D2E7; tumor necrosis factor-alpha human monoclonal antibody] - granted on 12/30/2002 to Abbott Laboratories for treatment of rheumatoid arthritis

DTaP & Hepatitis B & Polio Vaccine [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix; Infanrix + Engerix-B + IPOL] - a combination vaccine; approval granted on 12/13/2002 to GlaxoSmithKline Inc. for prevention of diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio; Poliovirus vaccine (mixture of three inactivated strains) is the only component not previously approved.

Parathyroid hormone (1-34), rDNA [teriparatide (rDNA origin); Forteo; LY333334; parathyroid hormone (1-34), recombinant] - granted on 11/26/2002 to Eli Lilly & Co. for treatment of osteoporosis

Interferon alfa-2a, rDNA, PEG- [Peginterferon alfa-2a; Pegasys; interferon alpha-2a, recombinant, pegylated] - granted on 10/16/2002 to Hoffmann-La Roche Inc. for first-line treatment of chronic hepatitis C

Urate oxidase, rDNA [uric acid oxidase, recombinant; rasburicase; re-Uox; Elitek; Fasturtec] - granted on 7/16/2002 to Sanofi-Synthelabo for control of plasma uric acid levels (hyperuricaemia) in pediatric patients receiving cancer chemotherapy resulting in tumor lysis and elevation of uric acid

Bone morphogenic protein-2, rDNA [bone morphogenetic protein-2, recombinant; BMP-2; INFUSE Bone Graft] - PMA granted on 7/2/2002 to Medtronic Sofamor Danek using recombinant bmp-2 (from Genetics Institue/Wyeth) as part of the INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device for treatment of certain types of spinal degenerative disc disease (lumbar spinal fusion)

DTaP Vaccine/Aventis Canada Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) [DAPTACEL] - BLA granted on 5/14/2002 to Aventis Pasteur, Ltd. for the first 4 doses of the diphtheria and tetanus toxoids and pertussis vaccination series administered to infants and children aged 6 weeks up to 7 years

Botulinum Toxin Type A Purified Neurotoxin Complex [BOTOX COSMETIC] - supplemental BLA granted on 4/12/2002 to Allergan, Inc. for temporary improvement in the appearance of moderate to severe glabellar lines ["frown lines"] associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age

Secretin, synthetic [SecreFlo; porcine secretin] - not a biopharmaceutical product (synthetic); granted on 4/5/2002 to Repligen Corp. for diagnosis of gastrinoma (tumors that secrete gastrin) and pancreatic disorders

Interferon beta-1a, rDNA/Serono [Rebif] - granted on 3/7/2002 to Serono, Inc. for treatment of relapsing forms of multiple sclerosis

CD20 Mab/Y-90 radioconj. [Ibritumomab Tiuxetan; Zevalin; a CD20 monoclonal antibody-chelating group conjugate] - granted on 2/29/2002 to IDEC Pharmaceuticals Corp. for treatment of B-cell non-Hodgkin's lymphoma; regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan

G-CSF, rDNA, PEG- [Pegfilgrastim; Neulasta; pegylated granulocyte-colony stimulating factor] - granted on 1/31/2002 to Amgen, Inc. for treatment of febrile neutropenia in patients receiving chemotherapy for non-myeloid malignancies

Further Information:

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets

Products database; Companies database - partial entries online

Reviews/Accolades

Biotechnology Information Institute - author/publisher's company home page

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets U.S. Approvals, 2002-Early 2021

BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets
U.S. Approvals, 2002-Early 2021