On 9 January 2026, Boan Biotech announced that it has received regulatory approval from Bolivia’s National Agency of Medicines and Health Technologies (AGEMED) for BA6101, its 60 mg denosumab injection, biosimilar to Amgen’s Prolia®. BA6101 is approved for the same indications as the reference product.
Boan Biotech’s denosumab biosimilars were approved in China in 2024 (Boluojia®; BA11021, referencing Amgen’s Xgeva®) and 2022 (Boyoubei®; BA6101, referencing Amgen’s Prolia®). 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 planned for Europe, the US 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’ 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), Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched), and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).