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The US FDA has approved Degevma, a biosimilar version of Xgeva (denosumab), following FDA approval of Ponlimsi (biosimilar, Prolia) in Mar 2026, with launch of both biosimilars anticipated in coming mos.
Approval was backed by extensive data, incl. analytical & clinical data showing similar efficacy, safety & immunogenicity profile as the reference product
Degevma prevents bone complications in adults with advanced cancer that has spread to the bone, treats giant cell tumors of bone in adults & skeletally mature adolescents, & manages hypercalcemia of malignancy
Ref: Teva | Image: Teva | Press Release
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The post Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva) appeared first on PharmaShots.
Teva Reports the US FDA Approval of Degevma (Biosimilar, Xgeva) | PharmaVoice