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.

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 ...

Xbryk is approved as prophylaxis for skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature ...

The approvals for Stoboclo/Osenvelt follow those for Ospomyv/Obodence and Jubbonti, biosimilars for Prolia, and Xbryk and Wyost, biosimilars for Xgeva. 8,9 1. Celltrion expands biosimilar portfolio in ...

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...