US FDA Accepts Alvotech and Teva Biosimilar Application for Eye Disease Treatment

The US Food and Drug Administration (FDA) has initiated a review of the Biologics License Application (BLA) for AVT06, a biosimilar candidate for the eye disease treatment Eylea (aflibercept). The application was submitted by Alvotech in collaboration with Teva Pharmaceuticals, with a regulatory decision expected by late 2025.

Eylea, used for conditions such as wet age-related macular degeneration and diabetic retinopathy, represents a significant market, with combined U.S. sales of the drug’s dosages reaching $4.77 billion in 2024. If approved, AVT06 would provide an alternative treatment option in the ophthalmology segment.

Alvotech’s submission follows the completion of clinical trials comparing the efficacy and safety of AVT06 to the reference product. Results reported in early 2024 indicated that the candidate met primary clinical endpoints, demonstrating therapeutic equivalence.

Beyond this filing, the two companies are also working on AVT29, a biosimilar candidate for the high-dose version of the treatment. Teva holds commercialization rights for both candidates in the United States.