Alvotech and Teva’s U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea, Accepted
Wednesday, February 19, 2025
Alvotech, a global biotech company focused on developing and manufacturing biosimilar medicines, and Teva Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for AVT06. AVT06 is Alvotech’s proposed biosimilar to Eylea (aflibercept), a biologic used to treat eye disorders that can lead to vision loss. The regulatory review process is expected to be completed in the fourth quarter of 2025.
Alongside AVT06, Alvotech is also developing AVT29, a biosimilar candidate for Eylea HD (aflibercept) 8 mg. Teva holds the U.S. commercialisation rights for both AVT06 and AVT29. Eylea is widely used for treating conditions such as neovascular (wet) Age-related Macular Degeneration (AMD), macular oedema, and diabetic retinopathy. In 2024, combined sales of Eylea’s standard and high-dose formulations in the U.S. reached $4.77 billion.
In January 2024, Alvotech reported positive results from a clinical study comparing AVT06 with Eylea in patients with wet AMD. The study confirmed therapeutic equivalence and similar safety profiles, including immunogenicity, between the two treatments.
AVT06 and AVT29 are recombinant fusion proteins designed as biosimilars to Eylea’s 2 mg and 8 mg doses. These candidates work by binding to vascular endothelial growth factors (VEGF), preventing receptor activation, neovascularisation, and increased vascular permeability. Both AVT06 and AVT29 remain investigational products and have not yet received regulatory approval. Biosimilarity has not been confirmed by regulatory authorities.
Source: alvotech.com
