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STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)  

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  • The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders 
  • Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events in adults with bone-involved cancers and for treating unresectable giant cell bone tumors 
  • Under their strategic partnership, Alvotech develops and manufactures denosumab biosimilars (AVT03) in Iceland, while STADA will hold marketing rights in EU, Central Asia, and the Middle East upon EU approval. The companies previously partnered on biosimilars for adalimumab and ustekinumab in EU 

Ref: STADA| Image: STADA | Press Release

Related News:- Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)

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