Clinical study results demonstrate therapeutic equivalence between biosimilar candidate AVT 06 and reference product Eylea (aflibercept)

Eylea is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy. In the last twelve months before September 30, 2023, cumulative global sales of Eylea were about US$9.4 billion [1].

The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT 06 compared with Eylea in patients with neovascular (wet) AMD. The primary outcome measure was change from baseline to Week 8 in Best-Corrected Visual Acuity (BCVA). The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea.

The Eylea patent is expected to expire in June 2027. Viatris' Mylan unit was the first to file for an Eylea biosimilar in 2021. Regeneron sued Mylan in August 2022, claiming that a proposed copy of Eylea infringed on the “11,084,865” patent, according to Endpoints News.