Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...more
Last month, in Amgen Inc. v. Coherus BioSciences Inc., the Federal Circuit affirmed a decision by the U.S. District Court for the District of Delaware dismissing a complaint filed by Amgen Inc. and Amgen Manufacturing Ltd....more
The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more