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

The FDA has approved the biologics license applications for Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, respectively.

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-dssb; SB16; 60 mg pre-filled ...

Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...

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

A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced ...

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 ...

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.

Interdisciplinary collaboration is key to reducing the risk for osteonecrosis of the jaw and improving patient care.

South Korea-based Celltrion today announced that the European Commission (EC) has granted marketing authorization for three ...