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]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight candidates targeting various diseases [11][12]. - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [13]. Product Details - AVT06 is intended for treating several 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]. Clinical Study Results - A confirmatory clinical study (AVT06-GL-C01) demonstrated therapeutic equivalence between AVT06 and Eylea®, meeting its primary endpoint [6]. Commercialization Rights - Alvotech is responsible for the development and commercial supply of AVT06, while Advanz Pharma holds exclusive commercialization rights in most European countries [5][7].