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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
Biotechnology Information Institute

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