Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce that the U.S. Food and Drug Administration (“FDA”) approved FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®, on June 28, 2024.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The FDA approval of FYB203/AHZANTIVE® is another key milestone on our way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of our team. With the Eylea® biosimilar FYB203/AHZANTIVE® and our already approved Lucentis®3) biosimilar FYB201, we have achieved an outstanding position in ophthalmic biosimilar therapies. We are thus improving healthcare for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options.”

FYB203/AHZANTIVE® obtained FDA approval for the treatment of patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO). The active ingredient inhibits the vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea® reached global sales of around US$ 9 billion4), confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.

The FDA approval for FYB203/AHZANTIVE® is based on a thorough evaluation of our comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203/AHZANTIVE® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).

In addition, a marketing authorization application for FYB203 was submitted to the European Medicines Agency (“EMA”) at the end of 2023. A decision by EMA is expected by early 2025 at the latest.

1) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
2) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
3) Lucentis® is a registered trademark of Genentech Inc.
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