Sandoz Launches First Interchangeable Denosumab Biosimilars in the US
Sandoz has launched WYOST® and Jubbonti® (denosumab-bbdz) in the United States, marking the availability of the first interchangeable biosimilars to Amgen’s XGEVA® and Prolia®.
Approved by the US FDA, the biosimilars match the reference products in form, administration, dosage, and indications. WYOST® is authorised for use in conditions related to cancer-related bone complications, giant cell tumours of the bone, and treatment-resistant hypercalcaemia.
Jubbonti® is indicated for multiple forms of osteoporosis, including those caused by hormone therapy and corticosteroids.
Both medicines are supported by reimbursement and financial assistance programmes. They are expected to help expand access to high-quality, cost-effective treatments for US patients, particularly those affected by osteoporosis and skeletal-related events due to cancer.
The biosimilars share safety profiles with their reference products, including risks such as hypocalcaemia, osteonecrosis of the jaw, atypical femoral fractures, and potential for severe allergic reactions.
WYOST® is also linked to vertebral fractures and hypercalcaemia after treatment ends. Jubbonti® carries a boxed warning for severe hypocalcaemia in patients with advanced kidney disease.
Patients are advised to be monitored regularly and to receive adequate calcium and vitamin D supplementation. The products are not recommended for use in pregnancy or for certain paediatric populations.
