U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products

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.

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.