Surprisingly, Amgen agrees with biosimilar competitor Mylan and the GPhA that FDA should use same international non-proprietary name (INN) for new biosimilar drugs to be consistent with current naming convention for biologics. This contrasts with the positions articulated by PhRMA and BIO who want unique names to "aid" pharmacovigilance and thus protect patients (their stated position). Amgen though says, "Since approved biosimilars will have no meaningful differences" in terms of their reference product protein (RPP), the two products should use the same names.
Though Amgen does waffle a bit in saying that FDA could use a "distinguishing component" in their non-proprietary name "in order to more readily and accurately identify, investigate and report adverse events." Presumably this would be the INN Jr. designation. Amgen appears to be walking the compromise line more carefully as they will be market participants in both the novel RPP and biosimilar space. I wonder if they are also signees on the PhRMA and BIO positions? See Biopharm-Reporter.com.
POsted by Bruce Lehr Sep 25th 2013.