Amgen And Samsung Bioepis Settle Denosumab BPCIA Case

On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. ("Amgen") and Samsung Bioepis Co., Ltd. and Samsung Biologics Co., Ltd. ("Samsung"), one day after Amgen and Samsung executed a Confidential Settlement Agreement.

As we reported previously, Amgen filed its BPCIA complaint against Samsung on August 12, 2024, asserting 34 patents. At issue were Samsung's denosumab biosimilars OSPOMYV" (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK" (denosumab-dssb; 120 mg vial), which reference Amgen's PROLIA^® and XGEVA^®, respectively. The FDA approved both biosimilars on February 13, 2025; OSPOMYV" for the treatment of osteoporosis in postmenopausal women and XBRYK" for the prevention of skeletal-related events in cancer patients. In the Consent Order, Samsung agreed that 21 of the asserted patents were "valid, enforceable and infringed" by Samsung's denosumab biosimilars. All other claims and counterclaims were dismissed with prejudice. The Consent Order did not go into any other terms of the Confidential Settlement Agreement.

The complaint against Samsung is the third of eight denosumab BPCIA litigations initiated by Amgen and the fifth to be settled, following settlements with Sandoz, Celltrion, Fresenius, and Accord BioPharma. Three denosumab cases filed at the end of June 2025 remain pending: Amgen Inc. v. Hickma Pharmaceuticals USA Inc. and Amgen Inc. v. Shanghai Henlius Biotech, Inc., both filed in the District of New Jersey, and Amgen Inc. v. Biocon Biologics, Inc., which was initially filed in the U.S. District Court for the District of Massachusetts, but was transferred to the District of New Jersey on July 15, 2025.

Stay tuned to Big Molecule Watch and follow our BPCIA Litigations Tracker to stay up to date on denosumab and other BPCIA litigation news.