The Reykjavik-based company has filed the application with the European Medicines Agency as a line extension to the existing marketing authorization for Mynzepli, its biosimilar to Eylea 2 mg, which received European Commission approval in August 2025.

Eylea (aflibercept) is used to treat certain retinal diseases through injections directly into the eye. According to the European product information, the 8 mg formulation allows some patients to be treated at sixteen-week intervals, compared with the standard eight-week maintenance interval for the 2 mg version. This could mean fewer injections and a lighter treatment burden for patients. The high-dose version has also gained ground quickly, accounting for around 57% of combined global Eylea sales by value in the second quarter of 2026, up from about 30% a year earlier, according to Regeneron’s reported results.

This is an important achievement for Alvotech and demonstrates the strength of our in-house development capabilities

“To our knowledge, this is the first regulatory submission anywhere in the world for a proposed biosimilar to Eylea 8 mg. This is an important achievement for Alvotech and demonstrates the strength of our in-house development capabilities,” says Lisa Graver, CEO, Alvotech. “We recognized early the potential of high-dose aflibercept and invested in developing both the 2 mg and 8 mg formulations.”

Under the partnership agreement, Alvotech is responsible for development and commercial supply, while London-based Advanz Pharma handles registration and commercialization in Europe. Advanz Pharma holds exclusive rights across Europe, except in Germany and France, where its rights are semi-exclusive.