Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars

South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; SB16; 120 mg vial), biosimilars of US major Amgen’s RANKL inhibitors Prolia and Xgeva, respectively. Additionally, the FDA granted a provisional determination for both Ospomyv and Xbryk’s interchangeability designation.

Drug Approvals

• Ospomyv is approved for:
  • Treatment of postmenopausal women with osteoporosis at high risk for fracture.
  • Increasing bone mass in men with osteoporosis at high risk for fracture.
  • Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
  • Increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
  • Increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
• Xbryk is approved for:
  • Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
  • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
  • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.-Fineline Info & Tech