The CHMP issues positive opinion for the marketing authorization of FYB203

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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 aflibercept.

In the joint press release¹ from Formycon AG and Klinge Biopharma GmbH, Dr Stefan Glombitza, CEO of Formycon AG, commented on this approval, saying, “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 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.”

FYB203 has been recommended by the CHMP for approval in Europe for treating adult patients with age-related neovascular macular degeneration (nAMD) and other serious retinal diseases such as diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularization (CNV), and macular edema following retinal vein occlusion (RVO).¹

The positive opinion issued by the CHMP marks a key regulatory step towards the approval of FYB203, which will go by the trade names AHZANTIVE and 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 2025.¹

FYB203 was approved by the US Food and Drug Administration (FDA) in June 2024.¹

Reference:

1. Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®. Formycon AG. November 18, 2024. Accessed November 18, 2024. https://www.eqs-news.com/news/corporate/formycon-receives-positive-chmp-opinion-for-fyb203-aflibercept-a-biosimilar-candidate-to-eylea-under-the-tradenames-ahzantive-and-baiama/2168417