Alvotech Files First Global Regulatory Application for Eylea 8mg Biosimilar
Alvotech (ALVO) has submitted AVT29 to the European Medicines Agency as a line extension to Mynzepli. The candidate is a proposed biosimilar to Eylea 8 mg, marking the first known regulatory submission worldwide for a biosimilar version of the high-dose retina treatment.
The filing expands Alvotech's eye-care strategy beyond its approved 2 mg biosimilar. High-dose Eylea accounted for approximately 57% of total Eylea sales in the second quarter of 2026. AVT29 offers a potential 16-week dosing schedule, which could reduce injection frequency for patients. Additionally, filing as a line extension may help streamline the review process by using the existing authorization footprint for Mynzepli.
Investors will be watching for regulatory feedback from European authorities and clear timelines toward potential approval and launch. If approved, Advanz will handle commercialization in Europe. Alvotech shares traded down 2.18% at $5.38 following the filing announcement.
Key points
- Alvotech submitted AVT29, a proposed biosimilar to Eylea 8 mg, to the European Medicines Agency.
- The submission represents the first known global regulatory filing for an Eylea 8 mg biosimilar.
- High-dose 8 mg formulations accounted for approximately 57% of total Eylea sales in Q2 2026.
- AVT29 was submitted as a line extension to Mynzepli, targeting a potential 16-week dosing interval.
- Advanz will handle commercialization of the biosimilar in Europe if approved.
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What did Alvotech submit to European regulators?
Alvotech submitted AVT29 to the European Medicines Agency as a line extension to Mynzepli. It is a proposed biosimilar to high-dose Eylea 8 mg.
Why is the AVT29 regulatory filing significant?
It marks the first known regulatory submission globally for an Eylea 8 mg biosimilar, targeting a high-dose segment that made up about 57% of Q2 2026 Eylea sales.
Who will commercialize AVT29 in Europe?
Advanz will handle European commercialization for AVT29 upon approval.