• Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of FYB203 for the treatment of Neovascular Age-Related Macular Degeneration (nAMD), along with several other serious retinal diseases
  • Approval decision by the European Commission expected in the second half of January 2025

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to Eylea®1 (aflibercept).

Dr. Stefan Glombitza, CEO of Formycon AG, commented: „We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea®. As our second ophthalmic biosimilar therapy following the success of our Lucentis®2 biosimilar, FYB203 represents a further advancement in treatment options for serios retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”

Under the tradenames AHZANTIVE®3/ Baiama®4 FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO).

Within the approval process, the CHMP’s positive opinion represents an important regulatory step towards the approval of FYB203/ AHZANTIVE®/ Baiama® in the European Union. The CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway, which is expected in the second half of January 2025.

Aflibercept 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 billion5, confirming its status as the currently best-selling drug in the field of anti-VEGF therapies.

FYB203 was approved by the U.S. Food and Drug Administration (FDA) in June 2024.



1) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2) Lucentis® is a registered trademark of Genentech Inc.
3) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
4) Baiama® is a registered trademark of Klinge Biopharma GmbH
5) Source: https://investor.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2023-financial/