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On March 31, 2026, the District Court for the District of New Jersey entered a Consent Order and Judgment in the BPCIA litigation Amgen brought against Henlius and Organon concerning their denosumab biosimilars, BILPREVDA® (denosumab‑nxxp) and BILDYOS® (denosumab‑nxxp), following a settlement between the parties. Under the consent judgment, Henlius and Organon agreed that all 26 asserted patents are valid, enforceable, and infringed by their denosumab biosimilars. All remaining claims and counterclaims were dismissed with prejudice.
This settlement follows Amgen’s settlement of denosumab litigations with Celltrion, Sandoz, Fresenius, Accord, Samsung Bioepis, Biocon, and Hikma/Gedeon. Amgen’s denosumab BPCIA litigations against Alkem, Dr. Reddy’s/Alvotech, and Amneal remain pending.
Denosumab is a human IgG2 monoclonal antibody that inhibits osteoclast activation, preventing the breakdown of bone. First marketed by Amgen as PROLIA® and XGEVA®, denosumab is used to treat conditions associated with bone loss, such as osteoporosis, and to treat bone cancers and prevent fractures in patients with bone metastases.
There are currently four pairs of denosumab biosimilars on the market, with Sandoz, Celltrion, Fresenius, and Hikma/Gedeon launching their respective products in 2025 and 2026. The Consent Order did not identify when Henlius and Organon will be allowed to launch their denosumab biosimilars.
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