Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
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
Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more