Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA).

Eylea® is used in the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. It inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. In the first nine months of 2023, Eylea reached global sales of around US$ 7 billion[[i]], underlining its status as the currently best-selling drug in the field of anti-VEGF therapies.

“Our latest MAA submission once again demonstrates the high performance and reliability of the entire #TeamFormycon. We are very pleased that with FYB203 we have filed our second biosimilar candidate in the ophthalmology space that is likely to become even more important in the coming years in light of the aging population.”, says Formycon CEO Dr. Stefan Glombitza.


1 Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.