A real-world cohort study finds that denosumab use is linked to a lower risk for incident knee osteoarthritis in adults with osteoporosis than the use of bisphosphonates.
Findings from a phase 3 trial showed denosumab-dssb had comparable efficacy, safety, immunogenicity, PK and PD to Prolia in patients with postmenopausal osteoporosis. Ospomyv is approved to treat ...
The US Food and Drug Administration (FDA) has approved denosumab-bnht (Conexxence/Bomyntra), manufactured by Fresenius Kabi, for all indications of the reference ...
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 ...
Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, received FDA approval for osteoporosis and bone loss treatment. Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics between ...
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for osteoporosis and bone loss in various patient populations. Stoboclo and Osenvelt ...
The Food and Drug Administration (FDA) has approved Stoboclo ® (denosumab-bmwo), a biosimilar to Prolia ® (denosumab), and Osenvelt ® (denosumab-bmwo), a biosimilar to Xgeva ® (denosumab). Stoboclo is ...
Please provide your email address to receive an email when new articles are posted on . Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and ...
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab ...