The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of FYB203, Formycon's biosimilar candidate to aflibercept (Eylea®). This decision paves the way for its potential use in treating neovascular age-related macular degeneration (nAMD) and other serious retinal diseases.
Regulatory Milestone
The positive CHMP opinion marks a significant regulatory milestone for FYB203, which will be marketed under the tradenames AHZANTIVE® and Baiama®. The recommendation supports its use in adult patients with nAMD, diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular edema following retinal vein occlusion (RVO).
Dr. Stefan Glombitza, CEO of Formycon AG, stated, "We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea®. 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."
Mechanism of Action and Market Impact
Aflibercept functions by inhibiting vascular endothelial growth factor (VEGF), a key driver of excessive blood vessel formation in the retina. Eylea® achieved approximately US$ 9 billion in global sales in 2023, underscoring its importance in the anti-VEGF therapy landscape. The introduction of biosimilars like FYB203 aims to increase patient access to these therapies through more affordable options.
Next Steps
The CHMP's assessment will form the basis for the European Commission's decision regarding marketing authorization, which is anticipated in the second half of January 2025. If approved, FYB203 will be available in all European Economic Area (EEA) countries, including the 27 EU Member States, Iceland, Liechtenstein, and Norway. FYB203 received FDA approval in June 2024.
