The FDA has approved the BLA for Ospomyv™ and Xbryk™, biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.

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

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).

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 ...

"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 ...

Lowering the price of the 2.5 mg dose vial to $349 per month. Lowering the price of the 5 mg dose vial to $499 per month.

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