On 24 November 2025, consent orders were made by the US District Court for the District of New Jersey recording that Hikma Pharmaceuticals and Gedeon Richter have entered into a confidential settlement agreement with Amgen to resolve pending BPCIA patent litigation in relation to denosumab. The terms of the settlement agreement are confidential but the consent orders provide that Hikma/Richter’s denosumab biosimilars cannot be launched in the US before at least 1 January 2026.
The litigation had been commenced by Amgen on 25 June 2025 asserting infringement of 32 US patents relating to denosumab. The lawsuit followed the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab). Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.
Amgen has now entered into seven US denosumab litigation settlements: Sandoz (Jubbonti® and Wyost® launched June 2025); Fresenius Kabi (global settlement) (Conexxence® and Bomyntra® launched early July 2025); Celltrion (Stoboclo® and Osenvelt® launched July 2025); Accord/Intas (settlement in July 2025, permitting launch of denosumab biosimilar from 1 October 2025); Biocon (Bosaya™ and Aukelso™ launched 1 October 2025) and Samsung Bioepis (settlement in early September 2025, launch dates remain confidential).
Amgen has pending US denosumab litigation against Shanghai Henlius/Organon (commenced 25 June 2025), Alvotech/Dr Reddy’s and Amneal/mAbxience (commenced 6 November 2025) and Alkem (commenced 14 November 2025).