Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more
On March 19, 2015, the District Court for Northern District of California (Judge Seeborg), issued an order providing one of the first judicial interpretations of the patent dispute resolution provisions laid out in subsection...more