Alvotech, Teva Pharmaceutical's Bionsimlar Eye Disorder Potential Treatment Accepted for FDA Review

MT Newswires Live

2025/02/18

Alvotech (ALVO) and Teva Pharmaceutical Industries' (TEVA) US affiliate said Tuesday that the US Food and Drug Administration has agreed to review a Biologics License Application for AVT06, Alvotech's proposed biosimilar to Regeneron Pharmaceuticals' (REGN) Eylea, as a potential treatment for eye disorders.

The companies said they anticipate Q4 regulatory approval for the drug.

The FDA review follows 2024 results from a clinical study of AVT06 which met its primary endpoint of therapeutic equivalence and comparable safety Eylea, the companies said.

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