Sandoz wins first FDA nod for bone drug biosims

06 Mar 2024
www.pharmamanufacturing.com
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Sandoz announced that it has notched the first and only FDA approvals for biosimilars to Amgen's two denosumab blockbusters, Xgeva and Prolia.
The biosimilars, Wyost and Jubbonti, were approved to treat all indications of the reference medicines. According to the FDA, both biosimilars were approved as interchangeable.
Jubbonti, the first interchangeable biosimilar to Prolia, is approved to treat osteoporosis and increase bone mass. Wyost, the first interchangeable biosimilar to Xgeva, is approved to prevent bone-related complications of cancer, including fracture, need for radiation to the bone, or spinal cord compression.
Both Xgeva and Prolia, which were first approved in 2010, have been top sellers for Amgen. ln 2023, the drugs brought in $2.11 billion and $4.05 billion for the drugmaker, respectively. Amgen is not ready to let go of its market share without a fight, either. According to Sandoz, "given ongoing patent litigation around these products," the drugmaker can't comment on the anticipated launch of the two newly approved biosimilars.
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