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

The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

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

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

The global osteoporosis drugs market was valued at approximately USD 8.93 billion in 2022 and is expected to grow at a healthy CAGR of more than 3.9% during the forecast period from 2023 to 2030.

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

South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European ...

Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.

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