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

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

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 ...

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

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 ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window Samsung Bioepis announced FDA approval of Ospomyv and Xbryk, biosimilars referencing denosumab (Prolia, Xgeva).

"Woman," "elderly," and "disabled" were among a list of banned words reportedly circulating within the FDA, which the White ...

The FDA approved Ospomyv and Xbryk, denosumab biosimilars that could expand access to treatment for osteoporosis, cancer-related bone loss, and other endocrine diseases. The 5 mg risdiplam tablet ...