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FDA Accepts Alvotech’s Eylea Biosimilar for Review

The regulatory approval process is expected to be completed by the fourth quarter of 2025.

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By: Charlie Sternberg

Associate Editor

Image courtesy of Victoria from Pixabay.

The U.S. Food and Drug Administration (FDA) has approved for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept), a biologic used to treat eye disorders, including those that can cause vision loss or blindness. Eylea is a widely used biologic for the treatment of eye disorders, such as neovascular (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. The regulatory approval process is expected to be com...

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