Alvotech and Advanz Pharma announced the submission of a European regulatory application for a biosimilar version of Regeneron’s high-dose Eylea (8 mg). It is the first known regulatory submission for a biosimilar to the higher-dose formulation, which is central to Regeneron’s Eylea strategy.
The 8 mg formulation has been a significant growth driver, accounting for about 57% of combined global Eylea sales in the second quarter of 2026. A high-dose biosimilar could accelerate competition and put pricing pressure on one of Regeneron’s most important products in Europe.