With Lawsuit Settled, Two Drugmakers Can Launch Denosumab Biosimilars Soon
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Feb 13, 2025
Amgen Inc. recently revealed that it had settled its patent infringement litigation against Celltrion Inc. over its denosumab biosimilar candidates that could allow them to launch onto the U.S. market this summer. The arrangement means that two different companies may be launching biosimilars of Amgen’s receptor activator of nuclear factor-kappa B ligand (RANKL) inhibitors Prolia and Xgeva on consecutive days.
The decision (No. 1:24-cv-06497-CPO-EAP), filed Jan. 23 in the U.S. District Court for the District of New Jersey, noted that the parties agreed that Celltrion’s products infringe on 29 Amgen patents. The court issued an injunction preventing Celltrion “from making, using, offering to sell, or selling” the biosimilars in the U.S. until June 1, 2025.
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