Biotech company Alvotech S.A. (NASDAQ:ALVO) and Teva Pharmaceuticals, a US affiliate of Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA), announced on Tuesday that the US Food and Drug Administration (FDA) has accepted the Biologics License Application for AVT06, a proposed biosimilar to Eylea (aflibercept).

The regulatory review is expected to conclude in the fourth quarter of 2025.

Alvotech is developing AVT06 as a biosimilar to Eylea (aflibercept) 2 mg, used for treating eye disorders such as neovascular (wet) age-related macular degeneration, macular oedema and diabetic retinopathy. The company is also advancing AVT29, a biosimilar candidate for Eylea HD (aflibercept) 8 mg, for which Teva Pharmaceuticals holds US commercialisation rights.

A confirmatory clinical study for AVT06 met its primary endpoint, demonstrating therapeutic equivalence, safety and immunogenicity compared to Eylea.

In 2024, combined sales of Eylea and Eylea HD in the United States reached USD4.77bn.