FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer

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FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva (denosumab).

These products bind to RANKL (receptor activator of nuclear factor kappa beta ligand), blocking its ability to bind to its receptor, a protein called RANK. Inhibition of the RANKL/RANK interaction helps prevent bone cells called osteoclasts from breaking down bone in the body. This is the first interchangeable biosimilar for a RANKL inhibitor.

Jubbonti is approved for the following treatment indications, which are also currently approved for Prolia:

postmenopausal women with osteoporosis at high risk for fracture;

increasing bone mass in men with osteoporosis at high risk for fracture;

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; and

increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Wyost is approved for the following treatment indications, which are also currently approved for Xgeva:

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; and

treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Both Jubbonti and Wyost are administered by subcutaneous injection and may be taken along with calcium and vitamin D as necessary to treat or prevent low calcium levels.

Source from FDA:https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-prolia-and-xgeva-treat-certain-types-osteoporosis-and

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