Sandoz secures regulatory approval for first biosimilar to Amgen’s Prolia and Xgeva

Pharma News: Sandoz ANZ has secured regulatory approval for its denosumab biosimilars, Jubbonti and Wyost, for the treatment of osteoporosis and cancer-related bone disease.

Clint Holland, General Manager of Sandoz Australia and New Zealand, said “We are proud of this milestone and this approval highlights our organisation’s continuous efforts to pioneer access to these life-changing medicines for patients.”

Amgen commercialised RANKL inhibitor denosumab as Prolia for osteoporosis in women and men and bone loss caused by other drug treatments, while Xgeva is used for a range of cancer indications, including bone metastases associated with solid tumours and multiple myeloma, giant cell tumours of the bone, and hypercalcaemia of malignancy.

Sandoz’ Prolia and Xgeva biosimilars – respectively Jubbonti and Wyost – have been approved for all of the indications of Amgen’s brands. Globally, Prolia is Amgen’s biggest-selling medicine, bringing in $4 billion last year.

Holland added, “As we approach our one-year anniversary as a standalone entity, Sandoz’s biosimilars growth pipeline remains strong. We are excited about the opportunities that lie ahead, and our business and people continue to remain focused on creating better health outcomes for all through access to biosimilars.”

Osteoporosis, a condition marked by decreased bone mineral density and compromised bone strength, affects over 850,000 Australians. This often symptomless disease can lead to fractures that are particularly prevalent among postmenopausal women and older men. Notably, half of all women over 50 will experience an osteoporotic fracture during their lifetime.

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