First Biosimilar to Eylea 8 mg Submitted in Europe
The application for AVT29 marks the first attempt to provide a biosimilar alternative to the high-dose aflibercept treatment.
Updated on Oct. 21, 2026 in Biotech
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Alvotech and Advanz Pharma have submitted a regulatory application to the European Medicines Agency for AVT29, a proposed biosimilar to Eylea 8 mg. This marks the first public regulatory filing for a biosimilar version of this high-dose aflibercept treatment.
Why it matters
The submission represents a shift in the competitive landscape for high-dose retinal treatments as developers move toward creating alternatives to established biologics. It signals the beginning of the regulatory process for providing lower-cost alternatives to the 8 mg formulation of Eylea.
The proposed biosimilar, AVT29, targets the 8 mg dosage strength of aflibercept, which carries a concentration of 114.3 mg/mL. This application follows the company's existing 2 mg Mynzepli product line authorization.
The players
Alvotech
A biotech firm focused on the development and manufacturing of biosimilar medicines for global markets.
Advanz Pharma
A pharmaceutical company specializing in the commercialization of complex medicines and specialty treatments in Europe.
European Medicines Agency
The decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines.
The details
AVT29 is designed as a biosimilar—a biological medical product highly similar to an already approved reference medicine—for the 8 mg dose of Eylea. Alvotech handles the development and commercial supply of the candidate, while Advanz Pharma maintains commercialization rights for the European market, excluding France and Germany. The companies submitted the candidate as a line extension to their existing authorization for Mynzepli, a move intended to streamline the regulatory pathway.
Timeline
October 14, 2026: Alvotech and Advanz Pharma announced the regulatory submission.
The Tech Race
This application marks the first attempt to challenge the market exclusivity of the 8 mg dosage of the Eylea platform via a biosimilar application. It sets a new milestone in the race to provide generic competition for high-dose aflibercept therapies.
The application is currently in the initial regulatory review stage and is not yet available for clinical use. Once approved, the product would offer clinicians and patients an alternative to the branded high-dose aflibercept, contingent on regional availability outside of Germany and France.
The takeaway
The industry is watching for the European Medicines Agency to provide feedback on this first-of-its-kind submission for an 8 mg aflibercept biosimilar. Stakeholders should track the official EMA register for upcoming procedural milestones regarding the AVT29 application.
Further reading
For more on the evolving landscape of high-dose retinal therapies, see Biotech.
Source note: This article includes information reported by Big Molecule Watch.
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