On 30 October 2026, China-headquartered Boan Biotech announced that it has licensed BA6101 (denosumab), biosimilar to Amgen’s Prolia® (marketed in Japan as Pralia®), to an undisclosed partner for Japan.
Under the agreement Boan Biotech’s partner has exclusive commercialisation rights to BA6101 in Japan and is responsible for regulatory submission, market access, promotion and sales of the biosimilar in the Japanese market. Boan Biotech will receive an upfront payment, milestone payments and royalties on sales.
BA6101 (marketed as Boyoubei® in China) was approved in China in November 2022 (with BA1102 (Boluojia®), referencing Amgen’s Xgeva® (denosumab) first approved in China in 2024) and in Bolivia in January 2026. In November 2025, Boan’s MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA). Boan Biotech 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, in May 2026. Boan Biotech is expecting approvals in the UK and US within the next year.
Boan Biotech also intends to seek marketing authorisation for BA6101 in other countries and regions and has established a network of partners to commercialise the drug, including in the US, Southeast Asia, and Latin America.
There is one approved denosumab biosimilar in Japan to date, Alvotech/Fuji Pharma’s AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection; September 2025), biosimilar to Daiichi Sankyo’s Ranmark® (marketed in other countries as Amgen’s Xgeva®). On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating therapeutic equivalence to Amgen’s Prolia®. SPD8 was co-developed by GlycoNex with Mitsubishi Gas Chemical.