Formycon AG announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for FYB203 (AHZANTIVE®/Baiama®), an aflibercept biosimilar candidate referencing Eylea®. This decision paves the way for potential approval in the European Union for treating several serious retinal diseases.
The positive CHMP opinion supports the use of FYB203 for adult patients with neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular edema following retinal vein occlusion (RVO). These conditions represent significant causes of vision loss worldwide.
The recommendation is grounded in a comprehensive evaluation of analytical, preclinical, clinical, and manufacturing data. The data package demonstrated that FYB203 exhibits comparable quality, efficacy, safety, and immunogenicity to the reference product, Eylea®, in patients with nAMD. This comparability is crucial for biosimilar approval, ensuring patients receive a treatment option with similar clinical outcomes.
The CHMP’s scientific assessment report will now be reviewed by the European Commission, which is expected to make a final decision regarding marketing authorization in the second half of January 2025. If approved, FYB203 will offer a more cost-effective alternative to aflibercept, potentially increasing patient access to this important treatment.
Aflibercept is a recombinant fusion protein that acts as a vascular endothelial growth factor (VEGF) inhibitor. VEGF plays a critical role in angiogenesis, the formation of new blood vessels, which contributes to the pathology of nAMD, DME, and other retinal vascular diseases. By blocking VEGF, aflibercept can reduce vascular leakage and neovascularization, thereby preserving and improving vision.
The development of biosimilars like FYB203 is an important step in reducing healthcare costs and expanding treatment options for patients with retinal diseases. The positive CHMP opinion marks a significant milestone for Formycon and underscores the potential of biosimilars to improve access to essential medicines.
