Will Biosimilar Manufacturers Have to Wait? Sandoz Petitions Supreme Court for an Answer
Last week, Sandoz, the generic pharmaceuticals division of Novartis, petitioned the Supreme Court to review a Federal Circuit decision concerning a case involving Zarxio, its biosimilar version of Amgen’s Neupogen. At issue is the court’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA establishes an alternative pathway for FDA approval of biosimilars and patent-dispute resolution, allowing litigation prior to FDA approval and marketing of biosimilars.