On 23 July 2026, Accord BioPharma announced its US launch of Osvyrti® and Jubereq® (denosumab), interchangeable biosimilars to Amgen’s Prolia® and Xgeva®, respectively. The denosumab biosimilars are the first products of Accord developed and manufactured “end to end” by its parent company, Intas Pharmaceuticals.
Osvyrti® and Jubereq® were approved by the FDA in November 2025. Intas/Accord settled BPCIA litigation with Amgen in relation to the denosumab biosimilars in July 2025, with the settlement permitting their US launch from 1 October 2025 (subject to regulatory approval). The US launch of the products comes over 7 months after their European launch in December 2025 (Jubereq® and Osvyrti® having been EU-approved in May 2025).
Denosumab biosimilars have been approved and launched around the world by a variety of sponsors. In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), 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, launched October 2025), Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).