FDA Approves Sandoz Denosumab Biosimilars

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.