Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
In a corrected brief filed October 25, 2016, defendant-appellee Hospira responded to Amgen’s opening brief on the merits seeking to overturn a discovery ruling that kept Hospira’s cell culture media information secret. ...more
Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more
The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more
The Federal Circuit has denied Hospira’s motion to dismiss Amgen’s appeal of a discovery order in an underlying BPCIA district court litigation (Civil Action No. 15-cv-00839, D. Del.) and has instructed the parties to address...more