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 ...

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

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

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 ...

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.

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 ...

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 ...

Xbryk is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents ...

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 ...

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).