Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more
Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more
The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more