Alvotech and Advanz Pharma Receive EU Approval for Eylea Biosimilar Mynzepli

Alvotech and Advanz Pharma have received EU approval for Mynzepli, a biosimilar to Regeneron's Eylea. Mynzepli will be available in pre-filled syringe and vial form. This approval expands the treatment options for patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.

Reykjavik, Iceland and London, UK (July 2, 2025) — Alvotech (NASDAQ: ALVO) and Advanz Pharma have received European Commission approval for Mynzepli®, a biosimilar to Regeneron's Eylea® (aflibercept). The approval covers all European Economic Area (EEA) countries, including the 27 member states of the European Union, Norway, Iceland, and Liechtenstein [1]. Mynzepli® is available in both pre-filled syringe and vial formats, providing flexibility for healthcare providers.

The approval marks a significant milestone for both companies, as it expands treatment options for patients with various retinal diseases. Mynzepli® is indicated for multiple eye conditions, including wet age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization [2]. The approval follows positive clinical trial results announced in January 2024, which demonstrated therapeutic equivalence to Eylea® [3].

The European market for retinal disease treatment is valued at approximately $3 billion [4]. If approved in other major markets, such as the United States and Japan, Alvotech could gain access to even larger portions of the global Eylea® market. Biosimilars typically launch at 15-30% discounts to reference products, which could translate to substantial savings for European healthcare systems while maintaining revenue growth opportunities for Alvotech [5].

Alvotech, a global biotech company specializing in biosimilar medicines, and Advanz Pharma, a UK-headquartered global pharmaceutical company, have formed a strategic partnership to bring Mynzepli® to market. The approval of Mynzepli® is part of Alvotech's broader strategy to expand its biosimilar portfolio and increase market access for its products.

References:
[1] https://www.stocktitan.net/news/ALVO/advanz-pharma-and-alvotech-receive-european-approval-for-mynzepli-0z9e8shlnh48.html
[2] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15.
[3] Use of trademarks Eylea® is a registered trademark of Bayer AG.
[4] Alvotech (NASDAQ: ALVO). (2025). Alvotech Forward Looking Statements.
[5] Alvotech (NASDAQ: ALVO). (2025). Alvotech Forward Looking Statements.