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Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar
On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories Ltd., Ascend Laboratories, LLC, and Enzene Biosciences Ltd. (“Alkem”) related to Alkem’s submission to the FDA of a Biologic License Application (“BLA”) seeking approval to manufacture and sell biosimilar versions of Amgen’s PROLIA and XGEVA products….
By: Goodwin