For example, the FDA-designated official non-proprietary (Established; official; compedial) names to be used for marketing and prescription purposes will be the first and most obvious thing (after the trademark) that everyone encounters.  Besides being used for prescriptions (safety and traceabilty issues involved), these names control the underlying perceptions of products (e.g., high-end distinct or low-end generic? related to another product(s) or not? comparisons-based or full approval?).  FDA has yet to give any indication of its policies for biosimilar established names.  Will these names be specific for the finished product or the active agent?  Will FDA stick with the current fully ambiguous use of the same name for both product and agent?  Will names be based on and track (change with) BLAs (be approvals-based; vague, easily gamed) and/or the agents/products (be entity/science-based, potentially complex), and what about product drift?  Will established names be fully unique, even meaningless?  Or will names be descriptive, perhaps, indicative of biosimilarity; and if so how, e.g., using common stems with prefixes/suffixes, and based on what relationships?  Will names be arbitrary, inconsistent, follow no rules, or will a coherent nomenclature system by used?  Will FDA abandon use of USANs/INNs for biopharmaceutical established names (as it needs to and has done with several recent approvals)?  If products get unique names, don't we also need unique nonproprietary names for the active agents?  Should and will the same nomenclature also apply to innovator/reference products, and should these products be renamed?  And aren't biosimilar/biogeneric (or class) names also needed for products and active agents?  Note, these issues arise even before considering the further complications posed by biobetters (rather similar products but different enough to get full approvals) and biogenerics (i.e., biosimilars with interchangeabilty/substituteability)! 

These are difficult issues with broad ramifications, all being ignored.  With biosimilars, FDA will de facto be providing nomenclature that will obviously be used for all biopharmaceuticals, including reference products.  To date, there has been much grandstanding and posturing promoting unique vs. (bio)generic established names.  No one has yet to even begin to address the substantive issues, including those cited above.  This includes no input sought from the chemical/pharmaceutical information community. 

Someone (or, ideally, multiple organizations representing diverse interests) needs to provide recommendations for product nomenclature and names relevant to the needs of diverse user communities and also publicy track/identify marketed products, particularly in the context of biosimilars.  But, essentially all organizations that should already have long been involved, including trade, professional associations and governments, have been avoiding these complex issues and/or have major conflicts-of-interest.  And with information needing to be freely disseminated, there is no incentive for private sector publishers to do the job. 

The U.S. BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products is proposed as, ideally, an industry-based and -funded collaborative scientific/educational project to provide what is needed. If interested please contact me. For further information, see the short proposal and Questions & Answers (but keep in mind, these represent just one potential approach to accomplishing the same goals).