European Commission approves aflibercept biosimilar Mynzepli

AVT06, now approved for marketing in the EU as Mynzepli, is also under regulatory review in the United States and Japan. Image credit: ©artjazz – stock.adobe.com

Advanz Pharma and Alvotech announced that the European Commission (EC) has approved marketing authorization for Mynzepli (previously known as AVT06), a biosimilar to aflibercept (Eylea, Bayer and Regeneron). The biosimilar received approval for treatment of multiple retinal diseases including neovascular (wet) age-related macular degeneration (AMD), in a 40 mg/mL pre-filled syringe and vial.¹

AVT06 is also under regulatory review in the United States and Japan.

Alvotech, headquartered in Reykjavik, Iceland, and Advanz Pharma, headquartered in London, UK, issued a joint press release announcing the approval.¹ The marketing authorization is valid in the 27 member states of the European Union as well as Iceland, Lichtenstein and Norway. Mynzepli is approved for the same adult indications as the reference product aflibercept: neovascular AMD, diabetic macular edema, visual impairment due to macular edema secondary to branch or central retinal vein occlusion (RVO) and myopic choroidal neovascularization.

Alvotech shared positive top-line results from a clinical study in early 2024 confirming the efficacy, safety and immunogenicity of the biosimilar with the reference product. The study met its primary endpoint. The European Medicines Agency's Committee for Medicinal Products (CHMP) for Human Use adopted a positive opinion on the product.

Joseph McClellan, chief scientific and technical officer of Alvotech, commented on the approval in the press release."Timely access to effective therapies is essential for individuals affected by retinal diseases. With millions of Europeans impacted, the approval of Mynzepli represents important progress in providing innovative and affordable treatment options,” he stated.¹ “This helps to ensure that patients throughout Europe have improved access to vision-preserving care, regardless of financial or logistical barriers.

In 2025, European Economic Area has seen an influx of approvals for aflibercept biosimilars. In July, Alteogen received a positive CHMP opinion for aflibercept biosimilar EYLUXVI.² In January and February, the CHMP adopted positive opinions for three biosimilars: Pavblu and Skojoy, both³ from Amgen, and FYB203, marketed as Ahzantive by manufacturer Formycon.⁴

References

1. Advanz Pharma and Alvotech receive European approval for Mynzepli®, Biosimilar to Eylea®. Press release. Alvotech. Published August 21, 2025. Accessed August 21, 2025. https://investors.alvotech.com/news-releases/news-release-details/advanz-pharma-and-alvotech-receive-european-approval-mynzeplir

2. Harp MD. Alteogen receives positive CHMP opinion for aflibercept biosimilar EYLUXVI. Ophthalmology Times Europe. Published July 28, 2025. Accessed August 21, 2025. https://europe.ophthalmologytimes.com/view/alteogen-receives-positive-chmp-opinion-for-aflibercept-biosimilar-eyluxvi-ema-decision

3. Hayes H. European Medicines Agency CHMP adopts positive opinions for two aflibercept biosimilars. Ophthalmology Times Europe. Published February 3, 2025. Accessed August 21, 2025. https://europe.ophthalmologytimes.com/view/european-medicines-agency-chmp-adopts-positive-opinions-for-two-aflibercept-biosimilars

4. Hayes H. UK MHRA issues approval for Formycon aflibercept biosimilar FYB203 (Ahzantive). Ophthalmology Times Europe. Published February 25, 2025. Accessed August 21, 2025. https://europe.ophthalmologytimes.com/view/uk-mhra-issues-approval-for-formycon-aflibercept-biosimilar-fyb203-ahzantive-