FDA Approves Denosumab Biosimilars Jubbonti and Wyost

The Food and Drug Administration has approved Jubbonti^® (denosumab-bbdz) and Wyost^® (denosumab-bbdz), the first interchangeable biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.

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 Jubbonti approval also includes a Risk Evaluation and Mitigation Strategy program designed to inform prescribers of the risk of severe hypocalcemia in patients with advanced kidney disease. 

Wyost is indicated to prevent skeletal-related events 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.

For this approval, the FDA reviewed a comprehensive clinical data package, which included data from the phase 3 ROSALIA trial (ClinicalTrials.gov Identifier: NCT03974100). The study compared denosumab-bbdz to the reference product (Prolia) in 527 postmenopausal women with osteoporosis. Study participants were randomly assigned to receive the biosimilar or the reference product for up to 78 weeks of treatment. Findings showed the biosimilar denosumab was comparable to the reference product with regard to pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity.

The availability of Jubbonti and Wyost is still unclear as ongoing patent litigation precludes Sandoz from launching the products at this time.