Biosimilars to Denosumab Approved with an Interchangeable Designation

In March, the U.S. Food & Drug Administration (FDA) approved Jubbonti (denosumab-bbdz) as a biosimilar to Prolia (denosumab), with an interchangeable designation; and Wyost (denosumab-bbdz) as a biosimilar to Xgeva (denosumab), also with an interchangeable designation.¹

These agents are given by subcutaneous injection, and they bind to receptor activator of nuclear factor kappa beta ligand (RANKL), blocking receptor binding. These are the first interchangeable biosimilars for a RANKL inhibitor.

Jubbonti is approved for the same indications as Prolia, which includes the treatment of: 1) postmenopausal women with osteoporosis at high risk for fracture; 2) men with osteoporosis at high risk for fracture; 3) men and women with glucocorticoid-induced osteoporosis at high risk for fracture; 4) men at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer; and 5) women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Wyost is approved for the same indications as Xgeva, which includes: 1) prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; 2) 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 3) treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Labeling for Jubbonti will include a Risk Evaluation and Mitigation Strategy (REMS) to advise prescribers and patients about severe risks of hypocalcemia associated with denosumab use in patients with advanced chronic kidney disease, including dialysis-dependent patients.²

Due to ongoing litigation around these products, anticipated product launch date is not yet known.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer. U.S. Food & Drug Administration. 2024 Mar 5.
2. FDA approves Wyost (denosumab-bddz), an interchangeable biosimilar to Xgeva. Food & Drug Administration. 2024 Mar 5.