Alvotech and Advanz Pharma announced the approval of Mynzepli® across all European Economic Area countries for treating retinal diseases like neovascular age-related macular degeneration (AMD). The approval is based on a study comparing Mynzepli® with the reference biologic Eylea®, with global Eylea® sales reaching US$9 billion in 2024. Mynzepli® will be available as a solution for injection in a pre-filled syringe and vial, offering improved access to vision-preserving care in Europe. Alvotech’s biosimilar candidate AVT06 showed therapeutic equivalence to Eylea® in a clinical study, leading to the European Commission’s approval of Mynzepli® as a biosimilar. Mynzepli® (aflibercept) has been approved in all European Economic Area member countries for treating retinal diseases, including neovascular (wet) age-related macular degeneration. This approval was based on comprehensive data, including a confirmatory study comparing Mynzepli® with Eylea®. Advanz Pharma is focused on partnering with biopharma companies to bring medicines to patients, driven by dedicated employees and company values of entrepreneurship, speed, and integrity.
Alvotech has issued forward-looking statements regarding future growth, results, regulatory interactions, and market launches, acknowledging uncertainties and risks that could impact outcomes. Factors include funding availability, regulatory changes, economic conditions, and COVID-19 impacts. Alvotech disclaims liability for any losses related to these statements.
Advanz Pharma also made forward-looking statements in a press release, emphasizing the potential risks and uncertainties that could affect the company’s plans and outcomes. Despite reasonable assumptions, these factors could impact financial results and events described in the release. Mynzepli® (aflibercept) has been approved in all European Economic Area member countries for treating various retinal diseases, including neovascular (wet) age-related macular degeneration (AMD). The approval was based on comprehensive data, including a study comparing Mynzepli® with the reference biologic Eylea® in neovascular AMD patients. However, actual results may differ due to various factors, such as global economic conditions and market competition. Advanz Pharma and its affiliates are not obligated to update forward-looking statements in the press release, and past trends do not guarantee future outcomes. For media inquiries, contact Alvotech Global Communications and Investor Relations or Advanz Pharma Global Corporate Communications.
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Mynzepli® (aflibercept) approved in all European Economic Area member countries for treating retinal diseases including neovascular (wet) AMD. Approval based on comprehensive data, including confirmatory study comparing Mynzepli® with Eylea® in neovascular AMD patients.: Advanz Pharma and Alvotech receive European approval for