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Formycon receives EU approval for aflibercept biosimilar for the treatment of severe retinal diseases

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The European Commission has approved the biosimilar aflibercept (FYB203) from Formycon AG, Martinsried-Planegg, Germany, under the brand names AHZANTIVE® and Baiama® for the treatment of neovascular age-related macular degeneration (nAMD) and several other severe retinal diseases.

Formycon AG and its license partner Klinge Biopharma GmbH have been granted marketing authorization by the European Commission for Aflibercept (FYB203), a biosimilar to Eylea®. The drug, marketed under the brand names AHZANTIVE® and Baiama®, is approved for the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases such as diabetic macular edema (DME), myopic choroidal neovascularization (mCNV) and macular edema due to retinal vein occlusion (RVV).

Aflibercept acts as an inhibitor of vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina and can therefore impair vision. The reference product Eylea® generated global sales of around USD 9 billion in 2023, demonstrating the need for cost-effective alternatives such as FYB203.

Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The EU approval of FYB203, our biosimilar for Eylea®, marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE® and Baiama®, we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life.”

In mid-January 2025, Formycon entered into a license agreement with Teva Pharmaceuticals International GmbH for the semi-exclusive commercialization of FYB203 in large parts of Europe and Israel. An agreement was also reached on product supply. FYB203 received approval from the US Food and Drug Administration (FDA) in June 2024.

The approval extends to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein and Norway.


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