Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the...more
As we previously reported, Amgen sued Pfizer and its affiliate Hospira in July 2018 based on Hospira’s submission of an aBLA for a biosimilar of NEULASTA (filgrastim). That same month, Pfizer obtained FDA-approval and, in...more
Today, the Federal Circuit dismissed Amgen’s appeal from and mandamus petition regarding the U.S. District Court for the Delaware’s order denying Amgen’s motion to compel discovery for lack of jurisdiction under the...more