Key Takeaways

  • Alvotech and Advanz Pharma submitted a European application for AVT29, reportedly the first proposed biosimilar to Eylea 8 mg to reach regulatory submission

  • The high-dose aflibercept formulation supports treatment intervals of up to 16 weeks for certain patients, potentially reducing injection burden

  • AVT29 was submitted as a line extension to Mynzepli, the companies' European-approved biosimilar to Eylea 2 mg

Alvotech and Advanz Pharma have submitted 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.

According to the companies, the application represents the first regulatory submission worldwide for a proposed biosimilar to the high-dose aflibercept formulation, based on publicly available information. The application was submitted as a line extension to the existing European marketing authorization for Mynzepli (AVT06), Alvotech's biosimilar to Eylea 2 mg (aflibercept 40 mg/mL).

Eylea 8 mg allows treatment intervals of up to 16 weeks for certain patients, compared with the standard 8-week maintenance interval associated with the original 2 mg formulation, potentially reducing injection frequency and treatment burden.

The companies highlighted the growing adoption of high-dose aflibercept. According to publicly reported financial results, Eylea 8 mg accounted for approximately 57% of combined global Eylea 2 mg and 8 mg sales by value during the second quarter of 2026, compared with approximately 30% during the corresponding period in 2025.

Mynzepli received European Commission approval in August 2025 in vial and prefilled syringe presentations for the treatment of various retinal diseases.

Under the companies' partnership agreement, Alvotech is responsible for developing and supplying AVT06 and AVT29, while Advanz Pharma oversees European registration and commercialization. Advanz Pharma holds exclusive commercialization rights throughout Europe, except in Germany and France, where rights are semi-exclusive.