For all the talk about a predictable and appropriate FDA pathway for biosimilars, where’s the thinking about what happens after approval?
Since patient safety and product efficacy will be a justifiable cause of angst to wary physicians, how will biosimilars be detailed? And who will do the detailing? Will biosimilar manufacturers need to develop patient assistance programs? What about REMS issues (both IP and implementation)?
Can you say, “authorized biosimilars?”
(And what will Congress and the FTC have to say about that?)