On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The BLAs seek approval for all indications of the reference products.
Days earlier, on 26 May 2026, Boan Biotech announced that China’s National Medical Products Administration (NMPA) approved its supplemental application for Boluojia® (BA11021) (denosumab injection 120 mg), biosimilar to Xgeva®, for the treatment of patients with bone metastases from solid tumours or multiple myeloma, to delay or reduce the risk of skeletal-related events (SREs), which include pathological fractures, spinal cord compression, and bone-directed radiation or surgery. Boluojia® was first approved in China in May 2024 for the treatment of giant cell tumour of bone.
Boan Biotech’s Boyoubei® (BA6101) was approved in China in November 2022 and in Bolivia in January 2026. In November 2025, Boan Biologics’ MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA). According to Boan Biotech, regulatory submissions for its denosumab biosimilars are also planned for Europe and Japan, among other regions.
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), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).