Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars executives.

So far, IP issues have kept U.S. launches to a trickle. Since the Biologics Price Competition and Innovation (BPCI) Act of 2009 created the regulatory pathway for biosimilars, FDA has approved 12 products. Only four have launched, while seven are waiting for the expiration of exclusivity for reference products or are the subject of legal disputes about when they can enter the market. ...