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.
The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...
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 OSPOMYVâ„¢ (denosumab ...
OSPOMYV™ and XBRYK™ approved by the U.S. Food and Drug Administration (FDA) for all indications referencing Prolia and Xgeva, respectively Samsung Bioepis’ first endocrinology biosimilar to ...
Meanwhile, the acquisition of Immunex Corporation gave Amgen access to the multi-blockbuster drug, Enbrel ... by its blockbuster growth drugs like Prolia and Xgeva. Other products are Repatha ...
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for troriluzole for the treatment of adults with spinocerebellar ataxia (SCA).
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