On 2 September 2025, Shanghai Henlius and Organon announced that the FDA has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.
Shanghai Henlius/Organon’s denosumab biosimilars are the fifth pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (launched June 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (launched July 2025), Celltrion’s Stoboclo® and Osenvelt® (launched July 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched).
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.
In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products. Amgen also has pending BPCIA litigation against Hikma/Gedeon Richter and Biocon in relation to denosumab. On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.