FDA Approves Sandoz Denosumab Biosimilars | Goodwin
On March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen’s XGEVA and PROLIA. These are the first and only FDA-approved denosumab biosimilars. Denosumab is indicated for bone metastasis from various forms of cancer and for the prevention of bone pain and fractures, including osteoporosis-related injuries. Both WYOST and JUBBONTI are approved to treat all indications of the reference medicines.
As we have previously reported, in May 2023 Amgen filed a BPCIA complaint against Sandoz in the District of New Jersey related to Sandoz’s denosumab biosimilar.
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