REG-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 (aflibercept 114.3 mg/mL), which they believe is the first such submission worldwide. The application was filed as a line extension to the European marketing authorization for Mynzepli, Alvotech's approved Eylea 2 mg biosimilar, potentially offering 16-week treatment intervals versus eight weeks for the 2 mg formulation. The high-dose segment is growing fast: the 8 mg formulation 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.

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