Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals (NYSE:TEVA) said on Tuesday that the U.S. FDA has accepted for review a Biologics License Application for a biosimilar targeting Regeneron’s (REGN) blockbuster eye disease therapy,

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.

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.

Key Takeaways Teva Pharmaceutical Industries and partner Alvotech said the Food and Drug Administration agreed to review their AVTO6 treatment for eye disorders. The treatment is a biosimilar that could compete with Regeneron Pharmaceuticals’ Eylea.