Ospomyv provided similar BMD increases as Prolia for women with osteoporosis in a phase 3 trial.
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent skeletal-related events for people with multiple myeloma and other indications, Samsung Bioepis announced.
Ospomyv (Samsung Bioepis) has been approved as a biosimilar referencing the osteoporosis therapy Prolia (Amgen). The biosimilar was approved to treat osteoporosis in postmenopausal women at high risk for fracture; treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture; and to increase bone mass in men with osteoporosis at high risk for fracture, men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and women at high risk for fracture receiving adjunct aromatase inhibitor therapy for breast cancer. Ozpomyv comes in a 60 mg prefilled syringe.
Xbryk (Samsung Bioepis) was approved as a biosimilar referencing the bone cancer therapy Xgeva (Amgen). The treatment is indicated to prevent skeletal-related events for people with multiple myeloma or bone metastases from solid tumors; to treat adolescents and adults with a giant cell tumor of bone that is unresectable or in cases where surgical resection is likely to result in severe morbidity; and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. Xbryk is distributed in a 120 mg vial.
Approval of the biosimilars was based on analytical, nonclinical and clinical data. In a phase 3 randomized controlled trial published in The Journal of Clinical Endocrinology & Metabolism in September, postmenopausal women with osteoporosis receiving Ospomyv had a mean 5.63% increase in lumbar spine bone mineral density at 1 year compared with a 5.3% lumbar spine BMD increase for those receiving Prolia. Ozpomyv also induced similar increases in total hip BMD and femoral neck BMD at 6 months and 1 year compared with Prolia.
"The FDA approval of Ospomyv and Xbryk marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the U.S.," Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a press release. "By providing quality-proven biosimilars, we are helping to address a critical health care need and reduce the burden of skeletal fractures that impact patients' quality of life. This achievement underscores our commitment to health care innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas."
The two new approvals come almost 1 year after the FDA approved the first biosimilars for denosumab. As Healio previously reported, the FDA approved Wyost (Sandoz), a biosimilar interchangeable with Xbryk, and Jubbonti (Sandoz), a biosimilar interchangeable with Prolia, in March 2024.