FDA Reviews AVT-06 Biosimilar for Eye Disorders
Alvotech and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT 06, Alvotech’s proposed biosimilar to Eylea (aflibercept), 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 the fourth quarter of 2025.
In addition to AV T06, which is a biosimilar candidate for Eylea (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea HD (aflibercept) 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 (wet) Age-related Macular Degeneration (AMD), macular edema, and diabetic retinopathy. In 2024, sales of Eylea (low dose and HD combined) in the U.S. were $4.77 billion.
In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT 06 with Eylea in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating therapeutic equivalence and comparable safety including immunogenicity between AVT06 and Eylea.
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