Senators ask FDA for biosimliar naming rules
Lawmakers are prodding the FDA to come to a decision about biosimilar naming. The Wall Street Journal reports that senators have asked the regulator to issue rules soon, particularly because Novartis's Sandoz subsidiary put a lookalike biologic up for review last month, and that drug will need a name.
Branded biologics makers want their drugs to have distinct international proprietary names—the ones that typically appear in parenthesis after a brand name, as in Rituxan (rituximab)—from those of copies. They have defended this position in part by saying a biologic made by another drugmaker would not be a duplicate of the original drug, so an almost-twin should not share the same name. The Journal notes that manufacturers of branded drugs have also defended this position by saying it would be easier to track adverse events if every biologic had its own name.
Opponents say that having distinct names for each biosimilar would make it harder to see a substitution as like-for-like.