On 5 September 2025, consent orders were made by the US District Court for the District of New Jersey recording that Samsung Bioepis and Amgen have entered into a settlement agreement resolving pending BPCIA patent litigation in relation to denosumab. The terms of the settlement agreement are confidential and the launch date for Samsung Bioepis’ denosumab biosimilars is unknown.
The litigation had been commenced by Amgen on 12 August 2024 against Samsung Bioepis and Samsung Biologics asserting infringement of 36 patents relating to denosumab. The lawsuit followed the filing by Samsung Bioepis of an aBLA with the FDA for its biosimilars (SB16) to Amgen’s Prolia® and Xgeva®. Samsung Bioepis’ biosimilars were approved in the US in February 2025 as Ospomyv™ and Xbryk™.
Amgen has now entered into five US denosumab litigation settlements. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025. Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024. Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025. Accord and Intas settled with Amgen in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025.
Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon.