Teva Pharma Secures FDA Nod For DEGEVMA, A Biosimilar To Xgeva
(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA as a biosimilar to Xgeva (denosumab).
The FDA approved DEGEVMA based on analytical and clinical data demonstrating efficacy, safety, and immunogenicity comparable to the reference product, Xgeva.
DEGEVMA is indicated for the prevention of bone complications in adults with advanced cancer that has spread to the bone, the treatment of adults and skeletally mature adolescents with giant cell tumour of bone, and the treatment of hypercalcemia of malignancy.
The comprehensive data package submitted to the FDA showed that DEGEVMA had no clinically meaningful differences from the reference product in terms of safety, purity, and potency, the company said.
The FDA approval of DEGEVMA, along with PONLIMSI (denosumab-adet), approved in March 2026, establishes a comprehensive U.S. denosumab biosimilar portfolio covering the indications of Xgeva and Prolia, respectively. DEGEVMA is also currently approved in the European Union (EU).
Teva expects to launch DEGEVMA and PONLIMSI in the U.S. in the coming months as part of its biosimilar commercialisation strategy.
TEVA has traded between $18.83 and $40.79 over the last year. The stock closed Monday's trade at $38.88, down 0.79%.
In the after-hours market, TEVA is up 0.31% at $39.00.
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