Another Way to Block Uptake with Biosimilars

You have to admit the innovators are doing a good job for their investors by pursuing every avenue at their disposal to block the quick introduction of biosimilars.  You have arguments for clinical trials, you have arguments against the FDA accessing info in BLAs (see Abbott) and now you have naming conventions.

What’s In A Name? A New Fight Over Biosimilars // Pharmalot.

The PhRMA and BIO trade groups are petitioning the FDA to require each biosimilar to have a unique non-proprietary name, purportedly to aid in pharmacovigilance. These groups say they want to be able to distinguish between the original drug and the biosimilar to insure patient safety.  But they really appear to want to put another hurdle in place that would prevent direct substitution or interchangeability - which of course should slow uptake of the biosimilar.

The GPA disagrees of course.  It wants biosimilars to follow existing drug-naming convention which is used globally. It further notes that the same international non-proprietary name (INN) has been given to biosimilars in other countries and regions. They note that medical knowledge of biologics and safety information is associated with the INN and a unique name woudl cause decoupling -- and ironically potentially hurt patient safety. Plus, they note.  There have not been a raft of safety issues with biosimilars in other geographies outside the US.

This debate boils down to money.  And clearly, from a policy standpoint, if biosimilars are delayed in their introduction in the US, much of the cost savigs that patients (and the healthcare system) might derive will be blunted.  Undoubtedly, successful launch of biosimilars will decrease prices for biologics (by how much?), but it should also increase uptake (volume) of these traditionally very expensive medicines in many parts of the world.  The net effect remains to be seen...........

Posted by Bruce Lehr Jul 13th 2012.

 

Comments

[Ronald A. Rader]

The issue of U.S. biosimilar (and biopharmaceutical) nomenclature is way more complex than portrayed in this, BIO, PhRMA, GPhA and other terse simplistic public discussions of the topic to date. For much background information and discussions of some of the many complex issues involved, visit www.biopharmacopeia.com (and also check out the embryonic www.biosimilars.com site).

The U.S. biopharmaceutical, including biosimlar, industry needs functional product and active agent nomenclature, whether it be unique, (bio)similar/quasi-generic and/or (bio)generic. Unless there is more substantive discussion, FDA will surely impose INN/USAN (current status quo for biopharmaceuticals) or some derivative, which in my view would be totally inadequate and unsuited for biosimilars and U.S. needs. INN/USAN nomenclature is based solely on active agents and designed for use as generic names for drugs/chemical substances, not as names for either biosimilar/biopharmaceutical active agents or finished products - an obvious dysfunctional mismatch. Yet so far, this is what both sides, innovator and generic, are proposing -- either adopt INN/USAN (as generic names) or adapt INN/USAN (jury-rig the names, e.g., add prefixes, suffices, Greek letters, etc., to make them unique)! To me (and anyone who looks into it), INN/USAN is totally unsuited for biopharmaceutical) product names, much less more highly nuanced biosimilar products.

I welcome all with any interest in these topics contacting me. Thank you.

Ronald A. Rader
President
Biotechnology Information Institute
301-424-0255
biotech@biosimilars.com