Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) announced that the FDA has accepted for review a Biologics License Application, or BLA, for AVT06, Alvotech’s proposed biosimilar to Eylea, a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness. The process to obtain regulatory approval is anticipated to be completed in Q4 2025. In addition to AVT06, which is a biosimilar candidate for Eylea 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea HD 8 mg. Teva also holds commercialization rights for AVT29 in the U.S. Eylea is a widely used biologic for the treatment of eye disorders, such as neovascular (AMD, macular edema, and diabetic retinopathy. In 2024, sales of Eylea in the U.S. were $4.77B.
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