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EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech
Author: Jennie Crabbe
Biosimilar company Alvotech and its partner Advanz Pharma announced Aug. 15 that the European Medicines Agency (EMA) had accepted a marketing authorization application for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept).
The companies said the review process could be complete by Q3-2025.
Alvotech, of Reykjavik, Iceland, is responsible for the development and commercial supply of AVT06. Advanz, of the UK, is responsible for registration and has exclusive commercialization rights in Europe—except for France and Germany, where the rights are semi-exclusive. French pharmaceutical company Biogaran holds semi-exclusive rights for France.
Alvotech is also developing AVT29, a biosimilar candidate for Eylea high dose (8 mg). Advanz and Biogaran are also set to commercialize AVT29, for the same countries as AVT06.
