The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines.
This means that Sandoz’s Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are interchangeable for all indications of reference medicines Xgeva® (denosumab) and Prolia® (denosumab).
Keren Haruvi, President Sandoz North America highlighted that denosumab is a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events.
As US-approved biosimilars, Wyost and Jubbonti have the same dosage form, route of administration, dosing regime and presentation as the Xgeva® and Prolia®, which are are registered trademarks of Amgen Inc.
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About the biosimilar medicines
Based on data from Amgen, Jubbonti 60 mg/1 mL injection is a human monoclonal antibody that is designed to bind to the RANKL protein, an activator of osteoclasts.
Jubbonti
FDA shared that Jubbonti is approved for:
- osteoporosis in postmenopausal women who have a high risk of 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
- to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Wyost
Similarly, Wyost 120 mg/1.7 mL (70 mg/mL) injection is a human monoclonal antibody designed to bind to the RANKL protein.
FDA stated that Wyost is approved to:
- prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours
- treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity
- treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines. The approval is also accompanied by labelling with safety warnings.
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