Biotechnology company Alvotech SA (NASDAQ:ALVO) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for AVT06, its proposed biosimilar to Eylea (aflibercept 2 mg).

The biosimilar is intended for the treatment of several retinal conditions, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema, retinal vein occlusion and myopic choroidal neovascularisation.

If approved, AVT06 will be authorised for use across the European Economic Area, which includes all European Union member states as well as Norway, Iceland and Liechtenstein. Alvotech is responsible for development and supply, while UK-based Advanz Pharma will handle registration and has exclusive commercialisation rights in most European markets.

AVT06 met its primary endpoint in a confirmatory clinical trial, demonstrating therapeutic equivalence to Eylea in patients with neovascular AMD. Global sales of Eylea reached approximately USD9bn in 2024, with Europe accounting for one-third of that total.

Alvotech is also developing AVT29, a proposed biosimilar to the higher-dose formulation Eylea HD. Advanz Pharma has licensed distribution rights to both AVT06 and AVT29 in Europe.