Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the U.S. Food and Drug Administration (“FDA”) has accepted the biologics license application (“BLA”) for FYB203, a biosimilar candidate to Eylea® (Active Ingredient: aflibercept), for review (“File Acceptance”). The agency assigned a target action date of June 2024.

Eylea® is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. With global sales of around US$ 9.6 billion[i] Eylea® is currently the top-selling drug in this therapeutic area.

“The file acceptance by the FDA is another important milestone to bring our second biosimilar candidate in ophthalmology on track for approval in the U.S. FYB203 is an excellent complement to our ophthalmic portfolio and addresses an important as well as growing market for the treatment of severe retinal diseases,” says Formycon CEO Dr. Stefan Glombitza



Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.

[i] Regeneron Reports Fourth Quarter and Full Year 2022 Financial and Operating Results | Regeneron Pharmaceuticals Inc.0