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 ...

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

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

"Woman," "elderly," and "disabled" were among a list of banned words reportedly circulating within the FDA, which the White House called a misinterpretation of an executive order. (Reuters via Yahoo!) ...

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

Xbryk（Xgeva）已被批准用于预防多发性骨髓瘤患者和实体瘤骨转移患者的骨骼相关事件、治疗无法切除或手术切除可能导致严重发病率的骨巨细胞瘤成人和骨骼成熟的青少年患者，以及治疗对双膦酸盐疗法有抵抗力的恶性肿瘤高钙血症。

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 ...

OSPOMYV™ and XBRYK™ approved by the U.S. Food and Drug Administration (FDA) for all indications referencing Prolia and Xgeva, respectively Samsung Bioepis’ first endocrinology biosimilar to ...

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

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 ...

In addition, the FDA granted a provisional determination for both Ospomyv and Xbryk's interchangeability designation. OSPOMYV, referencing Prolia, has been approved for the treatment of ...