FDA approves Sandoz’s denosumab biosimilars
Betsy Goodfellow | March 6, 2024 | News story | Medical Communications | FDA, Jubbonti, Musculo-skeletal disorder, Sandoz, Wyost, denosumab
Sandoz has announced that the US Food and Drug Administration (FDA) has approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), which are the first and only FDA-approved denosubmab biosimilars, for the treatment of all indications of the reference medication.
Wyost is approved for: the prevention of skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumours; the treatment of adult and skeletally mature adolescents with giant cell tumour of bone that is unresectable, or where surgical resection is likely to result in severe morbidity; and the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
The second biosimilar, Jubbonti, is approved: for the treatment of postmenopausal women with osteoporosis at a high risk of fracture; to increase bone mass in men with osteoporosis at a high risk of fracture; to treat patients with glucocorticoid-induced osteoporosis with a high risk of fracture; and to increase bone mass in men at high risk of fracture receiving androgen deprivation therapy for prostate cancer and women at high risk of fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
The drugs both have the same dosage form, route of administration, dosing regimen and presentation as their respective reference medicines.
Keren Haruvi, president of Sandoz North America, commented: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most.”
Betsy Goodfellow
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