Alvotech and Advanz Pharma Announce Submission for Proposed Eylea 8 mg Biosimilar
On October 14, 2026, Alvotech and Advanz Pharma announced the submission of a European regulatory application for AVT29, a proposed biosimilar to Eylea® 8 mg (aflibercept 114.3 mg/mL), marketed as Eylea HD® in the United States. This is the first publicly announced regulatory submission worldwide for a proposed biosimilar to Eylea® 8 mg. The application was submitted to the European Medicines Agency as a line extension to the existing European marketing authorization for Mynzepli® (aflibercept 2 mg), Alvotech’s biosimilar to Eylea® 2 mg.
The 8 mg formulation allows longer treatment intervals for certain patients with retinal diseases, potentially reducing the frequency of maintenance injections, according to the approved European product information.
Under their partnership, Alvotech is responsible for AVT29’s development and commercial supply, while Advanz Pharma is responsible for registration and commercialization in Europe. Advanz holds exclusive commercialization rights in Europe, except in Germany and France, where its rights are semi-exclusive.
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