European Medicines Agency confirms acceptance of MAA for AVT 06, a proposed biosimilar to Eylea (aflibercept).- Alvotech + Advanz Pharma
Alvotech and Advanz Pharma, announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT 06, Alvotech’s proposed biosimilar to Eylea (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025.
Advanz holds European rights for AVT 06. In France and Germany the rights are semi-exclusive. French pharmaceutical company Biogaran holds semi-exclusive registration and commercialization rights for France.
Alvotech is also developing AV T29, a biosimilar candidate for Eylea high dose (8 mg). Advanz Pharma and Biogaran will also commercialize AVT 29, for the same countries as AVT 06.
In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between Alvotech’s biosimilar candidate and Eylea.
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