On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications. Accord plans to launch the denosumab biosimilars in the US in 2026.
In November 2024, Amgen commenced BPCIA proceedings against Accord/Intas, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture. The litigation followed Accord/Intas’ submission of its abbreviated BLAs for its denosumab biosimilars. The US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025 (subject to regulatory approval).
There are a number of denosumab biosimilars approved and launched in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).