Background:
There is dire need for the development and refinement of the basic information paradigms,
taxonomies, definitions, terminology and nomenclature concerning biopharmaceuticals - how we think of, define,
classify, describe, name and regulate these products.
This includes neither FDA nor any other authority providing either usable unique or
biosimilar/(bio)generic names or basic descriptions/definitions for
marketed biopharmaceutical active agents and products.
The current situation is totally chaotic and inhibits U.S. commerce, e.g., affecting perceptions of both biosimilars and innovative/reference products.
Current systems and names were designed for chemical substances and drugs.
Specifically, new nomenclature and registry
systems are needed for biopharmaceuticals, particularly biosimilars (and interchangeables, biobetters,
biogenerics and agent/product drift); plus FDA and/or manufacturers need to disclose more descriptive
information about agents' and products' identity (largely defined by bioprocessing).
Goals
: The
BIOPHARMACOPEIA™ project will prospose unique and generic (similar) nomenclature for biopharmaceutical products
and active agents from a U.S.-centric perspective, and will integrate this with other nomenclature and identifiers at a
public Registry Web site. Candidate official unique and
(bio)generic nomenclature will be provided for products and active agents for selective adoption by regulatory
agencies, formularies, other reference sources, medical and pharmacy professionals, press, industry analysts, etc.
Impact
: Through its development of taxonomies and nomenclature from basic chemical/pharmaceutical information principles; provision of candidate official and other nomenclature; and the public Web site providing the most authoritative product and active agent nomenclature, the
BIOPHARMACOPEIA
™ Registry will be the dominant information resource in its field, and will help establish the core paradigms for how we define, characterize and think of biopharmaceuticals and biosimilars.
The
BIOPHARMACOPEIA
™ Registry will also be a potent force influencing the regulatory and scientific/medical communities and public perceptions concerning biopharmaceuticals and biosimilars. Depending on sponsorship, the Registry could include outreach, educational and advocacy/lobbying efforts.
In many respects, the
BIOPHARMACOPEIA
™ project may be similar to the CTFA/PCPC
Dictionary
, with the main U.S. cosmetics trade association publishing names almost always adopted by FDA for cosmetic ingredient labeling.
Sponsorship
: Ideally, this will be funded on a long-term basis as an independent unbiased scientific institution by one or more biopharmaceutical companies, trade associations or other source(s). If this is not attainable, it may be funded as a for-hire, consulting project, in which case it will likely reflect the interests of its sponsors (e.g., innovator or biosimilar companies).
Bottom Line
:
The
BIOPHARMACOPEIA
™ Registry will profoundly affect the information infrastructure,
perceptions, marketing and
regulation of biopharmaceuticals and biosimilars. Sponsorship will provide high impact, visibility and be highly cost-effective.
If you have significant vested interests in
biopharmaceuticals, you cannot afford to miss this opportunity to make
sure your views are represented. Please
contact
us regarding your
interests in this project.
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Someone (or, ideally, multiple organizations representing diverse interests) needs to provide recommendations for biopharmaceutical product/agent nomenclature and names relevant to the needs of diverse user communities and also publicly track/identify marketed products, particularly in the context of biosimilars.
But, essentially all organizations that should already have long been involved, including trade, professional associations and governments, have been avoiding these complex issues and/or have major conflicts-of-interest. And with information needing to be freely disseminated, there is no incentive for private sector publishers to do the job.
Ideally, FDA (and other countries) will do what is needed in terms of providing both unique and biosimilar/(bio)generic names/identifiers for their approved products and APIs. In parallel and, particularly, if FDA doesn't act, the U.S. BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products is proposed as an industry-based and -funded collaborative scientific/educational project to provide what is needed. But keep in mind, these only represent potential approaches to accomplishing the same goals.
Links are provided below to publications by the Web master, Ronald A. Rader, concerning
biopharmaceutical and biosimilar nomenclature systems, terminology, and the state of the infrastructure (or rather lack) of information resources supporting the biopharmaceutical industry.
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Over 7 Years and No Response from FDA!
Citizen Petition filed June 21, 2013.
See also Press Release, June 24, 2013; and the
Contract Pharma guest editorial, Sept. 2013.
FDA Citizen Petition Requests Improved Biopharmaceutical Nomenclature and Public Information
- The Biotechnology Information Institute has filed a Citizen Petition
(Docket no. FDA-2013-P-0776/CP1; 6/21/2013) requesting FDA assign both unique and biosimilar/(bio)generic-type (or class) names (and/or other identifiers) for approved biologic products and their
active agents, along with disclosures of sufficient public information to enable an adequate understanding of product identity,
what the products/agents are, which is largely dependent on their composition, bioprocessing and quality-related (CMC) aspects.
- Currently, there are no non-proprietary names (and no related nomenclature systems) for FDA-approved biologics designed to reflect the
nature of the products (and active agents), what they are, vs. being highly constrained by regulatory requirements. Similarly,
there exist no biosimilar/(bio)generic or class names for approved biologics.
- This petition also requests: unique names/identifiers and related public information disclosures concerning supplemental BLA changes in products/agents (product drift);
that any nomenclature for names/identifiers be coherent, science/product/entity-based and unencumbered by legacy regulatory requirements (as are official/Established/compendial/USAN names); and that names and related product/agent-defining information, including composition, bioprocessing and quality-related (CMC) aspects, be disclosed prior to and discussed at pre-approval public advisory committee meetings.
- Contact me for further information.
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published in
BioProcess International, June 2011, by Ronald A. Rader, President,
Biotechnology Information Institute
"Nomenclature of Biosimilars Will Be Highly Controversial"
Abstract: The names to be used for biosimilars (and biogenerics and biobetters) will be highly controversial, including the official nonproprietary names
to be designated by FDA for U.S. marketing and prescription purposes. Will these be fully unique or quasi-generic? Will names reflect
biosimilarity and if so, by what criteria (e.g.,
structure, product class, indications, be indicative of the reference product or not, etc.)? And how will this be done? Should there a system and
consistency among official names? What exactly will names be assigned to? -- What is a product, and what changes in a product require assigning a new
name? Who will coordinate and disseminate nomenclature?
The U.S.
BIOPHARMACOPEIA Registry of Biophaarmaceutical Products is proposed to help resolve these problems.
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published in Nature Biotechnology, July 2008, 26(7), p. 743-751, by
Ronald A. Rader, President,
Biotechnology Information Institute
"Re(Defining) Biopharmaceutical"
Abstract: This peer-reviewed article updates and synthesizes
much of my prior two-part series, "What is a Biopharmaceutical?," and other articles (available below).
This includes discussion of the various definitions of 'biopharmaceutical'; the complexities of these agents/products and what differentiates
biopharmaceuticals from drugs (chemically-derived, chemical substance-based pharmaceuticals), including the process=product paradigm; the flaws and
problems caused by the aberrant definitions in common use promoted by vested interests, including in the context of biosimilars/follow-on proteins; and
proposes actions to resolve these problems, including the
U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products.
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published in BioProcess International, March and May 2007, by Ronald A. Rader, President, Biotechnology Information Institute
"What Is a Generic Biopharmaceutical? Biogeneric? Follow-On Protein? Biosimilar? Follow-On Biologic?"
Part 1: Introduction and Basic Paradigms
Abstract: The concepts, paradigms, terminology and definitions concerning generic biopharmaceuticals (biosimilars, biogenerics, biobetters, etc.) are still in a primitive state. Use of essentially all current terms may support, denigrate or obfuscate various views and discussions of the topic, e.g., to many 'biosimilar' evokes negative connotations from association with generic drugs and/or suggests that products are identical, rather than similar/related.
There are three basic views/paradigms/definitions of generic biopharmaceuticals. Entity-based views concentrate on the products and active agents, including chemical structures and the unique aspects imparted by their biological source/identity, manufacturing process and specifications (process=product paradigm). Regulatory-based views concentrate on biopharmaceuticals as being approved or on track for approval as biosimilars (involving abbreviated filings based on comparative testing, sometimes therapeutic equivalence/substitution). Market/commercial-based views concentrate on products as competing for similar/same indications, having similar names, or any other perceived similarities. Depending on the view/paradigm/definition used and whether one takes a world or just Western (major market)-centric view, there are currently either many (hundreds), some or just a few biosimilar/biogeneric products in commerce; and follow-on biosimilars/biogenerics have either been around for a century or more, a few decades, a just a few years.
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Part 2: Information, Nomenclature, Perceptions, and the Market
Abstract: Because of their complexity,
biopharmaceutical products defy use of various
conventional chemical and
pharmaceutical information paradigms and
methods that work well
with drugs and other chemical
substances. Before one can deal with biosimilars, difficult questions must be answered, e.g., What
defines a biopharmaceutical agent or
product as unique and distinct from
others?; And, what entity-, regulatory-,
and/or market-based changes in an
agent or product require it to be
considered a new, different one? Biopharmaceuticals
will have to be defined, named, and tracked. But how should names be assigned, particularly to biosimilars? Should generic/similar names be
assigned, facilitating marketing as generics but likely decreasing safety, or
should unique names be assigned, favoring safety but likely decreasing the cost savings
generic offer? Both unique and (bio)generic names for
both finished products and active
ingredients will be required for different uses/users. However, current nomenclature systems are
inadequent for biopharamceuticals, e.g., with systematic nomenclature (IUPAC and CAS) designed to index the chemical literature, and nonproprietary
pharmaceutical nomenclature (USAN and INN) designed to handle small molecule, particularly generic, drugs.
New paradigms, terminology,
taxonomy, and nomenclature systems
are needed for biopharmaceuticals,
particularly ones that include
biosimilars. This industry maturation
will be painful, requiring industry and regulators to define products, their relationships and develop related
information resources and educational
programs. The U.S.
BIOPHARMACOPEIA Registry of Biopharamceuticals will assist in this process by developing new nomenclature systems, candidate names and a public Registry of biopharmaceutical products.
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published in the March and May 2005 issues of BioExecutive, by Ronald A. Rader, President, Biotechnology Information Institute:
"What is a Biopharmaceutical?"
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Part 1:
(Bio)Technology-Based Definitions
- This reviews the four very different basic views/paradigms/definitions of what is a biopharmaceutical, concentrating on
technology-based definitions, and the terms and definitions used by U.S. and European Union regulatory authorities.
- Part 2:
Company and Industry Definitions
- This reviews and critiques the views/paradigms/definitions of 'biopharmaceutical' no longer linked to biotechnology, with these aberrant definitions often adopted by many
in the financial community, press, companies and even major U.S. trade associations (BIO and PhRMA).
Abstract - Pharmaceuticals are composed of two major subsets - biopharmaceuticals and drugs (the vast majority). Biopharmaceuticals are pharmaceuticals inherently, usually obviously, biological in nature (e.g., proteins, cells) manufactured using biotechnology (involving live organisms). A derivative view limits this to recombinant proteins. Two other common views/paradigms/definitions ignore linkage to biological nature/biotechnology and take business/market-centric views. These either include as being biopharmaceuticals any/all pharmaceuticals connected with a biotechnology-like (small, entrepreneurial) company or that otherwise can be portrayed as being high-tech; or simply consider all pharmaceuticals to now be biopharmaceuticals (i.e., the drug/pharmaceutical industry is now the biopharmaceutical industry). These later two views are very common, but are dysfunctional, e.g., they arbitrarily include many or even all small molecule and other drugs (pharmaceuticals inherently chemical, not biological, in nature and manufactured by chemical means). With the biopharmaceutical industry lacking its own trade organization representing its interests [and sponsoring projects such as the BIOPHARMACOPIEA], the widespread misuse, cooptation and obfuscation of 'biopharmaceutical' (and 'biotechnology') places the underlying definitions, identity and public perception of the industry at risk to public relations, lobbying and rebranding efforts; and confounds discussions of biopharmaceuticals and related issues, e.g., biosimilars.
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"Nomenclature and Registry Systems for
Biopharmaceuticals and Biosimilars":
[The links below provide access to sections of a large draft article, much of which is discussed more briefly in the ""What Is a Generic Biopharmaceutical?..." articles above].
Abstract:
There are no simple ways to define and assign useful nomenclature (names and other identifiers) to specific biopharmaceutical products, including biosimilars, which add further levels of complexity. This includes names that are unique, unambiguous and useable (relatively short, pronounceable, etc), and generic names that convey information regarding entity, activity, therapeutic equivalence/substitution, class or other relationships among products. Nomenclature systems that work well for chemical substances and drugs fail when applied to biopharmaceuticals, biosimilars, biobetters and biogenerics. This article discusses problems with conventional drug/chemical nomenclature and registry systems as applied to biopharmaceuticals, and the controversies likely to be associated with selection of official names, both unique and generic, for biopharmaceuticals, particularly biosimilars. Nomenclature, since it greatly affects marketing, particularly the names to be officially adopted (for filling of prescriptions) for biosimilars, will be a very contentious issue.
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