Simply stated, BIOPHARMA covers all current, near-term upcoming, recently denied or withdrawn and other human biopharmaceutical products products in the U.S. and European markets. 'Biopharmaceuticals" refers to pharmaceuticals (medicinal products) manufactured by biotechnology methods/processes (generally involving live biological components/organisms; bioprocessing).
Coverage includes all biotechnology-derived products currently or recently approved by FDA or in Europe (EU or European countries) for therapeutic indications or used in vivo, e.g., radiolabeled monoclonal antibody radiodiagnostics. This includes all microorganism and animal cell and tissue-derived proteins, vaccines, blood products, antibodies, enzymes, cytokines, radioimmune conjugates and certain engineered tissue grafts/implants.
Products are included irrespective of whether they involve old (e.g., fermentation) or new (e.g., recombinant DNA, monoclonal antibody) biotechnologies. Note, coverage includes vaccines and blood products, often not considered as biopharmaceuticals by others who restrict their use of the term to recombinant proteins and monoclonal antibody-based products.
Coverage includes biopharmaceuticals irrespective of their regulation as biologics, drugs, or medical devices. Most of the products covered are biologics. Products regulated as drugs (e.g., recombinant versions of certain hormones, enzymes and natural products) and medical devices (e.g., recombinant sutures) are also included.
Various borderline biopharmaceuticals are also included, e.g., antisense oligonucleotides. Coverage does not include products generally considered to be (and often regulated as) drugs/chemical substances, such as antibiotics (although most are produced by biotechnology methods), botanicals, and other natural products.
Interested in problems and issues involved in how to define "biopharmaceutical?" See the author's article, "(Re)Defining Biopharmaceutical" published in Nature Biotechnology and his two-part series of articles, "What is a Biopharmaceutical?," Part 1: (Bio)Technology-Based Definitions and Part 2: Company and Industry Definitions, and other information at the U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products Web site].
Please inform us of any products that should be in the database.
Monographs include all on-hand publishable information, placed within fields/sections for the sake of ease of presentation and understanding. Every product monograph is handled independently, with no forcing of division of complex, intricately-related information into fields/sections. Thus, various types of information may be found in other fields/sections (e.g., some biological activity information may be discussed in the Description). The length of sections and product monographs varies greatly.