Some major points:

• A basic presumption of the author and the great majority of others in the industry (>85% in a recent survey), particularly in the U.S., is that biopharmaceutical is a subset of pharmaceutical, i.e., that biopharmaceuticals are pharmaceuticals inherently (usually, very obviously) biological in nature and manufactured using biotechnology (involving use of live organisms), while drugs comprise the other major subset of pharmaceuticals, with their source and manufacture being chemical (non-biological) in nature.
• Small molecule and other drugs are not biopharmaceuticals!
• Despite its definition and use being rather clear to most, there are many diverse definitions and views of what is (and is not) a biopharmaceutical (and biotechnology).
• Many outside the industry, including many in the financial community and press/media, and many within the pharmaceutical and biotechnology industries, including the major U.S. biotechnology and pharmaceutical trade associations (BIO, PhRMA), purposely redefine and use the term much more broadly, ignoring or even disavowing linkage to or involvement with biotechnology, and almost always with little or no consistency. Caution! Many promulgating these abberant views/paradigms/definitions of what is biopharmaceutical (and biotechnology) seek to rebrand and redefine these products, the industry and themselves to promote their own vested interests.
• Four major views, definitions or paradigms of biopharmaceutical are identified:
  1. Broad Biotechnology - Biopharmaceuticals are defined as pharmaceuticals manufactured by biotechnology methods, with the products obviously having biological sources, usually involving live organisms or their active components (bioprocessing; also usually very obvious; or directly involving surrogates, e.g., protein/gene sequences). This broad view has been adopted by Biopharmaceuticals in the U.S. and European Markets, which includes all recombinant proteins, (monoclonal) antibodies, vaccines, blood/plasma-derived products, nonrecombinant culture-derived proteins, and cultured cells and tissues. This is the view/definition most used/favored by those within the U.S. biopharmaceutical industry, and probably best understood by the public.
  2. New Biotechnology - This view or definition only includes those products based on platform technologies developed in recent decades, usually only including recombinant proteins and monoclonal antibodies as being biopharmaceuticals, leaving out nonrecombinant cultured proteins, blood/plasma proteins, vaccines and other classes of products. This view/definition is more predominant in Europe, e.g., European Union formal definitions, or is used by those whose primary/sole interest is in recombinant and monoclonal antibody products. Many obvious biopharmaceutical products are classed as as 'old' or simply ignored, including many products developed and approved recently and incorporating more recent/newer technology than many recombinant proteins and monoclonal antibodies (which are based on now 'old' technologies, invented in the 1970s and commercialized in the 1980s).
  3. Biotechnology Business - This company-centric view or definition simply includes all/everything from biotech-like (smaller, entrepreneurial, R&D-intensive) pharmaceutical and life science companies as being biopharmaceutical; plus obvious biopharmaceuticals from large companies (Big Pharma). All/every non-Big Pharma pharmaceutical or life sciences company is viewed as a biopharmaceutical company. By this view/definition, products, technologies and companies need not have any involvement or use of biotechnology to be called biopharmaceutical. Those using this definition/view include many in the press, stock analysts and, regrettably, the Biotechnology Industry Organization (BIO). Many small drug R&D and service companies also describe themselves as biopharmaceutical companies, including those designing or developing small molecule drugs, even when their products, technologies and companies have absolutely no use or involvement with biotechnology.
  4. Pharma Business - This view simply includes all pharmaceuticals as biopharmaceuticals, i.e., biopharmaceuticals is used as a synonym for pharmaceuticals; and the pharmaceutical industry is now the biopharmaceutical industry. Biopharmaceuticals are no longer a subset of pharmaceuticals, with biopharmaceuticals now taking in all pharmaceutical and (Boolean OR) biotechnology companies (with a health care orientation). Much of this (mis)use may be traceable to what this author views as the myth of convergence. Various industry analytical reports, including those funded and issued by the Pharmaceutical Research and Manufacturers Association (PhRMA), assert that the pharmaceutical industry (dominated by Big Pharma) has just recently morphed or transformed itself into the biopharmaceutical industry as a result of the "convergence" of biotechnology and pharmaceutical industries/technologies; that the pharmaceutical industry, through adoption of new technologies and close relationships (primarily outsourcing, contracting and licensing) with biotech companies, has undergone a fundamental change; and that 'new' and 'revolutionary' technologies, e.g., high-throughput screening and drug design methodologies, are biotechnologies and have fundamentally changed the industry. [Thus, everything in the pharmaceutical universe is now biopharmaceutical].
• This author disagrees with the later three views, particularly the Biotech and Pharma Business views/paradigms/definitions. These simply consider to be biopharmaceutical (or biotechnology) all/anything involving small, R&D-intensive biomedical or life sciences (biotech-like) companies or related high-tech R&D; or all/anything pharmaceutical. Even the lay public understands that biopharmaceuticals involve biotechnology!