Amgen advocates for distinguishable non-proprietary names in substantial comments to GPhA and Novartis biosimilar naming citizen petitions
By Kurt R. Karst – There’s a hot debate brewing over whether or not a biosimilar biological product licensed under Section 351(k) of the Public Health Service Act (“PHS Act”), as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), should share the same non-propriatary name – or International Nonproprietary Name (“INN”) […]