The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...

Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics between denosumab biosimilars and reference products. Common adverse events for Ospomyv include back pain and ...

The FDA has approved the biologics license applications for Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, respectively.

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-dssb; SB16; 60 mg pre-filled ...

Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...

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 ...

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) ...

Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a ...

Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCEtm (60mg pre-filled syringe) and XBRYKtm (120mg vial), denosumab biosimilars ...