Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more