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Alvotech submits first global regulatory application for proposed biosimilar to Eylea 8 mg
ALVOAlvotech
Alvotech, in partnership with Advanz Pharma, has submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept). This marks the first known worldwide regulatory submission for this high-dose formulation. The application is filed as a line extension to Alvotech's existing marketing authorization for Mynzepli, its approved biosimilar to Eylea 2 mg. Advanz Pharma holds exclusive commercialization rights in Europe and will manage registration. Alvotech develops and manufactures biosimilar medicines.