Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions like unresectable giant cell tumors. Earlier this year, Samsung also received approval in Korea for a biosimilar to PROLIA, Amgen’s other denosumab product used to treat hormone-induced bone loss and postmenopausal osteoporosis.
We previously reported on FDA’s approval of Samsung’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®, respectively, and the European Commission’s marketing authorization of OBODENCE™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), again referencing Amgen’s PROLIA® and XGEVA®, respectively. With this domestic approval, Samsung has now secured regulatory approval for both of its denosumab biosimilars across all three major markets.
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