Alvotech and Advanz Pharma announce first known regulatory submission worldwide for proposed biosimilar to Eylea® 8 mg
Alvotech and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg, which they describe as the first known regulatory submission worldwide for this high-dose aflibercept product. The filing was made as a line extension to the existing European marketing authorization for Mynzepli, Alvotech's approved biosimilar to Eylea 2 mg, potentially accelerating the review path. The 8 mg formulation allowed 16-week treatment intervals for certain patients and accounted for roughly 57% of combined global Eylea 2 mg and 8 mg sales by value in Q2 2026, up from about 30% a year earlier.
Key figures
- Drug Name
- AVT29 (proposed biosimilar to Eylea 8 mg / aflibercept 114.3 mg/mL)
- Extended treatment interval
- 16 weeks vs 8-week standard for 2 mg formulation
- Eylea 8mg share of combined sales q2 2025
- 30%
- Eylea 8mg share of combined sales q2 2026
- 57%
AI analysis
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