Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule. Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA (“file acceptance”).

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.

“We are very delighted to bring our second biosimilar candidate in ophthalmology on formal track for approval in the U.S. I would like to thank our licensing partner Klinge for their continuous support as well as the entire Formycon Team for their great efforts. With FYB203 we are going to address an important as well as growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options,” says Formycon CEO Dr. Stefan Glombitza.

“The submission of the BLA for FYB203 is proceeding according to our initial planning and we have once again demonstrated the agility and expertise of our development organization. FYB203 is an excellent complement to our ophthalmic portfolio and in addition to our already approved ranibizumab biosimilar (FYB201), we are fully committed in making another highly effective treatment option available,” comments Formycon CSO Dr. Andreas Seidl.

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