U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products

Over 2 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.

U.S. BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products
(proposal only, so far.  This is just one potential approach to accomplishing the same goals - names and descriptions/definitions for marketed biopharmaceuticals!)
  • The current situation is totally chaotic and inhibits U.S. commerce.  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 U.S. BIOPHARMACOPEIA will propose candidate unique and non-unique names for biopharmaceutical products and their active agents suitable for selective adoption by diverse vested interests, uses and users, including regulatory agencies, formularies, reference sources, public use, etc.  This includes candidate names suitable for adoption as the science/product/entity-based unique and non-unique product identity-based names requested by the Citizen Petition, and candidate Established/official/compendial names.
  • The U.S. BIOPHARMACOPEIA™ Registry of Biophamaceutical Products Web site will coordinate and deliver product and agent names and related public information (and, thus, be among the most authoritative biopharmaceuticals information sources).