FDA Approves Formycon and Klinge’s Biosimilar to Eylea®

FDA Approves Formycon and Klinge’s Biosimilar to Eylea®

July 03, 2024

Formycon AG and its licensing partner Klinge Biopharma GmbH announced the U.S. Food and Drug Administration's (FDA) approval of FYB203/AHZANTIVE®, a biosimilar to Eylea®.

FYB203/AHZANTIVE® has been approved by the FDA 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).

CEO Stefan Glombitza Reflects on Milestone Achievement

Dr. Stefan Glombitza, CEO of Formycon AG, expressed his enthusiasm, stating, "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® 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."

The biosimilar works by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. Eylea®, the reference drug, achieved global sales of approximately US$ 9 billion in 2023, affirming its status as the best-selling drug in the anti-VEGF therapy category.

Comparative Data Validation

The FDA's approval of FYB203/AHZANTIVE® followed a comprehensive evaluation of Formycon's data package, encompassing analytical, pre-clinical, clinical, and manufacturing data. The biosimilar demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to Eylea® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).

Formycon AG and Klinge Biopharma GmbH have also submitted a marketing authorization application for FYB203 to the European Medicines Agency (EMA) in late 2023. A decision from the EMA is anticipated by early 2025 at the latest.

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