European Medicines Agency Recommends Approval of Alvotech's AVT06, Proposed Biosimilar to Eylea®
Reuters
Jun 23
European Medicines Agency Recommends Approval of <a href="https://laohu8.com/S/ALVO">Alvotech</a>'s AVT06, Proposed Biosimilar to Eylea®
Alvotech SA, in collaboration with Advanz Pharma, announced that the European Medicines Agency's $(EMA)$ Committee for Medicinal Products for Human Use $(CHMP)$ has adopted a positive opinion recommending market approval for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept 2 mg). This recommendation is a significant step towards marketing the biosimilar in the European Economic Area, which includes the 27 EU member states, Norway, Iceland, and Lichtenstein. The approval is intended for treating various eye disorders, including neovascular age-related macular degeneration and diabetic macular oedema. Alvotech is responsible for the development and commercial supply, while Advanz Pharma holds exclusive commercialization rights in most European countries.
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