EMA accepts Alvotech's marketing application for Eylea biosimilar

The European Medicines Agency (EMA) has formally accepted the marketing authorization application for AVT06, a biosimilar candidate to Eylea (aflibercept) developed by Alvotech. Regulatory clearance is anticipated by the third quarter of 2025.

Eylea is a widely prescribed biologic for treating retinal diseases, including wet age-related macular degeneration. In 2023, the drug generated global sales of $5.9 billion, with the European market accounting for $2.9 billion. The introduction of a biosimilar could significantly alter the competitive landscape for these high-cost eye treatments.

Alvotech retains responsibility for the clinical development and manufacturing of the product. Advanz Pharma holds the rights for commercialization and registration across most of Europe, while Biogaran holds specific rights for the French market. According to clinical data published by Alvotech in early 2024, the biosimilar demonstrated therapeutic equivalence to the reference product in trials involving patients with retinal conditions.