Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)

Core Insights - Alvotech and Teva Pharmaceuticals announced that the FDA has accepted the Biologics License Application for AVT06, a proposed biosimilar to Eylea, with regulatory approval expected by Q4 2025 [1][2] - Eylea, a biologic for treating eye disorders, generated $4.77 billion in sales in the U.S. in 2024 [3] - Alvotech is also developing AVT29, another biosimilar candidate for Eylea HD, with Teva holding commercialization rights in the U.S. [2] Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market with a fully integrated approach [7] - The company has two approved biosimilars for Humira and Stelara and a pipeline of nine additional candidates targeting various diseases [7] - Alvotech has established strategic partnerships for global reach, including collaborations with Teva, STADA, and others across multiple regions [7] Product Details - AVT06 and AVT29 are recombinant fusion proteins targeting vascular endothelial growth factors (VEGF) to inhibit neovascularization and vascular permeability [5] - A confirmatory clinical study showed that AVT06 met its primary endpoint, demonstrating therapeutic equivalence and comparable safety to Eylea [4]