On September 16, 2025, the FDA approved Biocon Biologics Ltd.’s BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) as biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. Both biosimilars have been approved for all indications of their reference products and granted provisional interchangeability designations.
BOSAYA™ and AUKELSO™ are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. According to the press release, both biosimilars were approved based on the review of clinical studies demonstrating comparable quality, safety, and efficacy to the reference product.
Biocon’s denosumab biosimilars are the sixth set of denosumab biosimilars to be approved by the FDA, behind Sandoz’s WYOST® and JUBBONTI® (denosumab-bbdz), approved in March 2024; Samsung Bioepis’s OSPOMYV™ and XBRYK™ (denosumab-dssb), approved in February 2025; Celltrion’s STOBOCLO® and OSENVELT® (denosumab-bmwo), approved in February 2025; Fresenius’s CONEXXENCE® and BOMYNTRA® (denosumab-bnht), approved in March 2025; and most recently, Shanghai Henlius Biotech and Organon’s BILDYOS® and BILPREVDA® (denosumab-nxxp), approved in August 2025. To date, Sandoz, Celltrion, and Fresenius have launched their biosimilar products in the United States.