Shanghai Henlius and Organon have settled US BPCIA litigation brought by Amgen in June 2025 in relation to their denosumab biosimilars, Bilprevda® and Bildyos® (HLX14), as recorded by a Consent Order and Judgment filed with the US District Court for the District of New Jersey on 31 March 2026. Henlius/Organon consented to an order that 26 US patents asserted by Amgen (relating to Amgen’s Prolia®/Xgeva® (denosumab)) are valid and infringed by making, using, selling or offering to sell Henlius/Organon’s denosumab biosimilars in the US, or importing them into the US.
There has been no announcement by the parties in relation to the settlement and whether a US launch date for Bilprevda® and Bildyos® has been agreed. Samsung Bioepis’ Q1 2026 Biosimilar Market Report had indicated the products had launched in the US in October 2025.
Bildyos® and Bilprevda® were approved in the US in September 2025. Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.
The BPCIA litigation against Henlius/Organon was one of a number of US proceedings brought by Amgen in relation to biosimilar denosumab, many of which have now settled. Amgen has entered into US denosumab litigation settlements with Sandoz (settlement in April 2024, Jubbonti® and Wyost® launched June 2025); Fresenius Kabi (March 2025 settlement, Conexxence® and Bomyntra® launched early July 2025); Celltrion (settlement in January 2025, Stoboclo® and Osenvelt® launched July 2025, following January 2025 settlement); Accord/Intas (settlement in July 2025, FDA approval of Osvyrti® and Jubereq® in November 2025); Biocon (Bosaya™ and Aukelso™ launched 1 October 2025 following settlement shortly after commencement of proceedings in June 2025); Samsung Bioepis (settlement in September 2025, Ospomyv® included on US formularies from 1 April 2026); and Gedeon Richter/Hikma (settlement in November 2025, Enoby™ and Xtrenbo™ launched in January 2026).
Amgen still has pending US denosumab litigation against Alvotech/Dr Reddy’s and Amneal/mAbxience (commenced 6 November 2025) and Alkem (commenced 14 November 2025).