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News|Articles|October 15, 2026

Alvotech files first known aflibercept 8 mg biosimilar with EMA

Author(s)Kassi Filkins

AVT29, filed as a line extension to Mynzepli, reaches EMA before its phase 3 comparative trial in DME reads out in mid-2027.

Alvotech and Advanz Pharma have submitted a European regulatory application for AVT29, a proposed biosimilar to high-dose aflibercept 8 mg (Eylea 8 mg; Bayer/Regeneron), already marketed as Eylea HD in the United States.1 The companies describe it as the first regulatory submission worldwide for a biosimilar to the 8 mg formulation.1

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