SANDOZ ANZ has received regulatory approval for two denosumab biosimilars, Jubbonti, for treating osteoporosis in post-menopausal women and, Wyost, for cancer-related bone disease.
Clint Holland, General Manager of Sandoz Australia and New Zealand, acknowledged the milestone, highlighting the company's dedication to improving access to life-changing medicines.
"As we near our one-year anniversary as a standalone entity, Sandoz's biosimilars pipeline remains robust," said Holland.
"We're excited about the future and our ongoing commitment to enhancing health outcomes through access to biosimilars."
Wyost is approved for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumours.
The drug also treats large cell tumours of bone in adults or skeletally-mature adolescents under certain conditions, as well as hypercalcaemia of malignancy refractory to intravenous bisphosphonate.
Bone is the third most common site for metastatic tumours, with cancers like breast and prostate frequently spreading to bones, causing pain and fractures.
The Australian Register of Therapeutic Goods registration supports the use of Jubbonti and Wyost for its listed indications.
Both biosimilars are bio- equivalent to their reference medicines, matching in dosage form, administration route, dosing regimen, and presentation.
Jubbonti is available as a pre-filled syringe with an automatic needle guard, while Wyost is offered as a solution for injection in a vial.
Sandoz has not yet disclosed details about the anticipated launch timing for the drugs. JG
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