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The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots:

  • The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab)
  • Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss
  • Additionally, Fresenius & Amgen reached a global settlement in Mar 2025, allowing the US launch of these biosimilars in mid-2025 & their European launch in late H2’25

Ref: Fresenius| Image: Fresenius| Press Release

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