FDA approves first denosumab biosimilars
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The FDA approved the first two denosumab biosimilars.
Denosumab-bddz (Wyost, Sandoz) is interchangeable with and approved for all indications of Xgeva (Amgen).
These include prevention of skeletal-related events among patients with multiple myeloma and patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable, or for cases when resection likely will result in severe morbidity; and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Denosumab-bddz (Jubbonti, Sandoz) is interchangeable with and approved for all indications of Prolia (Amgen).
These include to increase bone mass among men at high risk for fracture who are undergoing androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass among women at high risk for fracture who are undergoing aromatase inhibitor therapy for breast cancer; treatment of postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass among men with osteoporosis at high risk for fracture; and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
The Jubbonti approval is accompanied by approval of risk evaluation and mitigation strategy program designed to inform patients and prescribers about risk for severe hypocalcemia among patients with advanced chronic kidney disease.
“Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss — such as osteoporosis — as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients,” Keren Haruvi, president of Sandoz North America, said in a press release.