Core Insights - Alvotech has successfully defended against infringement proceedings initiated by Regeneron Pharmaceuticals and Bayer AG, allowing the company to continue manufacturing its biosimilar AVT06 in the UK [1][2] - The UK High Court's decision supports Alvotech's commercial launch of AVT06 in the European Economic Area and other regions following the expiry of Supplementary Protection Certificates for Eylea® on November 23, 2025 [1][2] - The approval of AVT06 as a biosimilar to Eylea® by the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) further strengthens Alvotech's market position [3] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market by providing high-quality, cost-effective products [5] - The company has two biosimilars already approved and marketed, with a pipeline of nine additional candidates targeting various diseases, including autoimmune disorders and cancer [5] - Alvotech has established strategic partnerships with multiple global companies to enhance its market reach and leverage local expertise [5] Product Information - AVT06 (aflibercept) is a recombinant fusion protein approved as a biosimilar to Eylea®, which inhibits vascular endothelial growth factors [4] - The product is currently under review in several countries, including the United States, indicating potential for further market expansion [4]

Core Viewpoint - The European Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), enhancing access to effective therapies for retinal diseases across Europe [1][3]. 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 of eight disclosed candidates targeting various diseases [9]. - Advanz Pharma is a UK-based global pharmaceutical company that specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [10]. Product Details - Mynzepli® is approved for treating multiple retinal diseases, including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME), available in a 40 mg/mL solution for injection [4][8]. - The approval is based on comprehensive data demonstrating the therapeutic equivalence of Mynzepli® to Eylea® [5][8]. Market Context - In 2024, global sales of Eylea® were approximately US$9 billion, with one-third of these sales occurring in Europe, indicating a significant market opportunity for Mynzepli® [3]. - The centralized marketing authorization for Mynzepli® is valid across all European Economic Area (EEA) countries, including the 27 EU member states, Norway, Iceland, and Lichtenstein [3].

Core Viewpoint - Alvotech and Advanz Pharma announced 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 disclosed candidates targeting various therapeutic areas [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 adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization [4][8] - In 2024, global sales of Eylea® were approximately US$9 billion, 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 for most European countries [5][7]

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]