On 22 December 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has approved Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively. The approval follows the FDA’s March 2025 acceptance for review of Amneal/mAbxience’s BLA for the denosumab biosimilars.
Under a partnership announced in October 2023, mAbxience is responsible for developing and manufacturing the denosumab biosimilars, while Amneal is pursuing regulatory approval and holds the exclusive US commercialisation rights.
Amneal/mAbxience’s denosumab biosimilars are currently the subject of US BPCIA litigation commenced by Amgen on 6 November 2025. Amgen is asserting infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.
Other denosumab biosimilars approved in the US include 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), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched) and Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched).