pharmaphorum March 6, 2024
Phil Taylor

Sandoz has claimed the first FDA approvals for biosimilars of Amgen’s blockbuster bone disease therapy denosumab, but has not said when it plans to launch them onto the US market.

Amgen sells 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.

Prolia is currently the company’s biggest-selling drug, bringing in $4 billion last year, including $2.7 billion from the US, while Xgeva is ranked at number four, contributing $2.1 billion overall and $1.5 billion in the US.

Sandoz’ Prolia and...

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