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

South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European ...

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

Two osteoporosis treatments from Samsung Bioepis have received product approval from the U.S. Food and Drug Administration (FDA) and the European Commission. The osteoporosis treatments Prolia and ...

U.S. President Donald Trump threatened to impose tariffs of around 25 percent on pharmaceutical imports on Tuesday, raising ...

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.

Samsung Bioepis' approvals mark their ninth and tenth medications, enhancing access to biosimilar treatments in the US. The FDA approved Ospomyv and Xbryk, denosumab biosimilars that could expand ...

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

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