Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar

Amgen filed a BPCIA complaint in New Jersey federal court against Alkem Laboratories, Ascend Laboratories, and Enzene Biosciences over Alkem's biosimilar application for PROLIA and XGEVA (denosumab). Amgen alleges Alkem failed to properly disclose BLA information during patent dance negotiations and imported infringing materials. The complaint asserts 35 patents and seeks injunctive relief and damages. This marks Amgen's eleventh denosumab biosimilar litigation, with five previous cases settled and others pending.