FDA Citizen Petition Requests Improved Biopharmaceutical Nomenclature and Public Information
ROCKVILLE, MD; June 25, 2013: The Biotechnology Information Institute (Ronald A. Rader, President) has filed a Citizen Petition requesting FDA improve its biopharmaceutical (biologics) nomenclature and public information disclosures. Mr. Rader noted, "These products and their active agents lack needed descriptive names and associated public information."
The petition requests FDA assign both unique and biosimilar/(bio)generic-type (or class) nonproprietary names to approved biologic products and their active agents, along with disclosures of associated public information to enable an adequate understanding of product identity, what the approved products/agents are, at any point in time. The petition further requests that candidate names and product/agent-defining information, including composition, bioprocessing and quality-related (CMC) aspects, be disclosed prior to BLA approvals and discussed at public advisory committee meetings. The Petition and further information are available at www.biopharmacopeia.com.
Mr. Rader is the author and publisher of BIOPHARMA: Biophamaceutical Products in the U.S. and European Markets, the only information resource/reference specializing in biopharmaceutical products (see www.biopharma.com), and soon to be launched, the most extensive biosimilars/biobetters pipeline database (see www.biosimilarspipeline.com). He noted, "Biopharmaceuticals (biologics) are the most complex of all commercial products. Yet despite this and their 100+ years of federal regulation, there exist no authoritative nonproprietary names that reflect the products' or active agents' identity, what they are, which is largely dependent on their composition, bioprocessing and quality (CMC) aspects."
Mr. Rader noted, "FDA needs to bring biologics into the 21st century and treat each as unique, including names, and disclose some associated useful descriptive product information. Biologic products and active agents with different bioprocessing and from different sources need relevant unique names/identifiers and product information disclosures, including as they evolve. And of course, biosimilar/(bio)generic/class names are needed too. With 100s of biosimilars expected to enter the market in the next 5 years, these products will quickly outnumber full BLA-approved products, and without sufficiently unique and biosimilar/(bio)generic-type names/identifiers, there will be total chaos."
Biologics are now recognized as each being unique, including each product/agent from each manufacturer's facility. Yet there exist no suitable nonproprietary unique names/identifiers that reflect product identify from any science/entity/productproduct-based perspective. The names/identifiers FDA currently assigns, including established (official; compendial; USAN) names, are all highly constrained by legal and regulatory requirements. Besides not reflecting the identity of products/agents (what they are) and not tracking related changes (product drift), these legacy pre-recombinant nomenclature systems are not adaptable for modern biopharmaceuticals. All other relevant nomenclature systems, including chemical nomenclature, e.g., CAS (IUPAC) Names and Registry Numbers, are inherently generic in their handling of biologic products/agents, with names/identifiers used to index and bring together, not differentiate, similar commercial products and their active agents.
Mr Rader also noted, "The public product documentation is now incredibly devoid of even the most basic information about what approved biologic products and agents are, what makes each unique and similarities with other products/agents. Examination of the approval reviews-related public documents available at the FDA Web site shows that there is very often negligible or no information concerning composition, bioprocessing and quality aspects being disclosed in the public domain!" FDA review documentation often includes 100% redaction (censoring) of relevant document sections (examples in petition Appendix 3). The petition requests that basic product/agent-defining and descriptive information be disclosed prior to BLA approvals and discussed at pre-BLA public advisory committee meetings.
Note for Media: If you've been covering biosimilars, you have likely reported about the issue of what type of official nonproprietary (established, compendial, USAN) names will be assigned to biosimilars. This is a very important issue (discussed in a recent publication by this author), but is not in any way involved with this Citizen Petition! This Petition seeks coherent science/entity/product-based nomenclature (both unique and biosimilar/(bio)generic/class names) for all biologics, with this new and unencumbered by laws and regulatory requirements. The established/official names to be used with biosimilars, such as whether to assign unique or generic names, will inherently be political compromises, needing to satisfy diverse legal requirements, uses and user communities. There will still be a need for the requested unique science/entity/product-based names. And of course, with biosimilars coming, there is a need for coherent biosimilar/(bio)generic/class names.
Ronald A. Rader
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Web sites: www.biopharmacopeia.com; www.biopharma.com; www.biosimilarspipeline.com