Icelandic biotechnology company Alvotech and Advanz Pharma have submitted an application to the European Medicines Agency, EMA, for AVT29, a biosimilar to Eylea 8 mg. According to the companies, it is the first regulatory application in the world for a biosimilar to the high-dose version. This is stated in a press release.
The application is an extension of the approval for Mynzepli 2 mg. Eylea 8 mg may enable longer treatment intervals for retinal diseases.
The high-dose version accounted for 57 percent of Eylea’s global sales in the second quarter of 2026, compared with 30 percent the year before.
