FDA approval for first and only denosumab biosimilars – Sandoz

Sandoz, announced that the FDA approved Wyost (denosuab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines

Keren Haruvi, President Sandoz North America, said: “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.

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. Bone is the third most frequent site for metastatic tumors. Nearly all types of cancer can spread to the bone and cause pain and fractures, though cancers that often metastasize in bones include breast and prostate.

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.

Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease or when bone strength and structure change. People living with osteoporosis typically do not have symptoms and might not know they have the disease until they experience a fracture. More than 10 million US adults aged 50 and over live with osteoporosis, a major cause of fractures in postmenopausal women and in older men. Half of all women over the age of 50 will experience an osteoporotic fracture during their lifetime.

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 Jubbonti 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. Wyost and Jubbonti are approved as interchangeable with the reference medicines for all indications.

Given ongoing patent litigation around these products, Sandoz will not comment on anticipated launch timing or other launch details at this statge.