The FDA approved the denosumab biosimilar Ospomyv, interchangeable with Prolia, for preventing osteoporosis-related fracture ...

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

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

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

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

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

Dialysis patients on denosumab (Prolia, Xgeva) had a lower risk for fracture but higher risk for a certain heart event, suggested an observational trial weighted to emulate a clinical trial.

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 ...

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.

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...

Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® ...

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar ...