FDA To Review BLA For Alvotech's Proposed Biosimilar To Eylea - Quick Facts

(RTTNews) - Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has accepted for review a Biologics License Application for AVT06, Alvotech's proposed biosimilar to Eylea, a biologic used to treat eye disorders. The process to obtain regulatory approval is anticipated to be completed in the fourth quarter of 2025.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular AMD.

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