On March 5, the the U.S. Food and Drug Administration (FDA) approved Jubbonti (denosumab-bbdz, 60 mg/1 mL injection), as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz, 120 mg/1.7 mL [70 mg/mL] injection), as an interchangeable biosimilar to U.S.-licensed Xgeva (denosumab).
Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors; to treat 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; and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
Jubbonti is approved to treat postmenopausal women with osteoporosis at high risk for fracture; to increase bone mass in men with osteoporosis at high risk for fracture; to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
The FDA approval is based on robust clinical studies and accompanied by labeling with safety warnings. The Jubbonti approval is also accompanied by approval of Sandoz’s Jubbonti Risk Evaluation and Mitigation Strategy (REMS) program, which is designed to inform prescribers and patients about the risk of severe hypocalcemia associated with the product in patients with advanced chronic kidney disease, including dialysis-dependent patients.
Wyost and Jubbonti have the same dosage form, route of administration, dosing regimen, and presentation as the respective reference medicines (Xgeva and Prolia); they are approved as interchangeable with the reference products for all indications.
