The 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 are the first interchangeable biosimilars for RANKL inhibitors.
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.
The side effects and adverse events observed in clinical trials of Jubbonti and Wyost are consistent with those observed with Prolia and Xgeva.
- The most common side effects of Jubbonti, like Prolia, were low blood calcium; back, joint, arm, leg and muscle pain;, common cold (runny nose or sore throat), and arthritis.
- The most common side effects of Wyost, like Xgeva, are tiredness/weakness, low phosphate levels in your blood, diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache.
Denosumab can cause serious side effects including serious infections, skin reactions, osteonecrosis, allergic reactions and hypocalcemia. It is unknown if the long-term use of denosumab time may cause slow healing of broken bones.
On January 19, 2024, FDA issued a Drug Safety Communication update to report that the agency added a boxed warning for increased risk of severe hypocalcemia (low blood calcium levels) in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). Jubbonti also has a boxed warning in the prescribing information, just as Prolia does. Patients on dialysis or with mineral and bone disorders are at highest risk for this adverse event.
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