SandozSandoz wins FDA approval for first two biosimilars for Amgen's blockbuster bone drug
05 Mar 2024
Drug Approval
Sandoz said Tuesday that the FDA signed off on two of its biosimilars to Amgen’s bone drug denosumab. But as with other high-profile biosimilar approvals, it’s unclear when either of the two new products might launch and how low prices may fall.
The approvals are the first sign that Amgen’s blockbusters Prolia, for osteoporosis in women after menopause, and Xgeva, which is indicated to treat bone cancer and bone problems in cancer patients, are going to lose market share. Prolia and Xgeva, the dual brand names for denosumab, collectively hauled in more than $6 billion last year for California-based Amgen.
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