European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

Core Viewpoint - Alvotech and Advanz Pharma have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval for AVT06, a proposed biosimilar to Eylea® [1][5] Group 1: Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines [11] - Advanz Pharma is a UK-based pharmaceutical company specializing in specialty, hospital, and rare disease medicines [13] Group 2: Product Details - AVT06 is intended for treating various eye disorders, including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) [4][8] - The global sales of Eylea® were approximately US$9 billion in 2024, with one-third of these sales occurring in Europe [5] Group 3: Clinical Study and Development - A confirmatory clinical study (AVT06-GL-C01) demonstrated therapeutic equivalence between AVT06 and Eylea®, meeting its primary endpoint [6] - Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, with Advanz holding distribution rights for both biosimilar candidates [7]