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Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea)

Shots:

  • The EC has approved Mynzepli (AVT06), a biosimilar version of Eylea (aflibercept) for all indications of the reference product in all 30 EEA states; AVT06’s Dossiers are under review in multiple regions incl. the US & Japan
  • Approval was based on extensive analytical, non-clinical & clinical data incl. a confirmatory study assessing Mynzepli vs Eylea in neovascular AMD, which met its 1EP, showing similar efficacy, safety, & immunogenicity between the two
  • Mynzepli targets VEGF to inhibit receptor activation, neovascularization, & vascular permeability, which is available as a 40mg/mL solution for injection in a pre-filled syringe & a vial 

Ref: Alvotech | Image: Alvotech & Advanz Pharma | Press Release

Related News:- Alvotech Partners with Advanz Pharma to Commercialize AVT10 (Biosimilar, Cimzia) in the EU

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