Planegg-Martinsried, Germany – Formycon AG [FSE: FYB] announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for FYB203, to be marketed as AHZANTIVE®/Baiama®, a biosimilar candidate to Regeneron's Eylea® (Aflibercept). This decision paves the way for potential approval in the European Union (EU) for treating several serious retinal diseases.
The CHMP's recommendation is based on a comprehensive evaluation of analytical, preclinical, clinical, and manufacturing data. The assessment concluded that FYB203/AHZANTIVE®/Baiama® demonstrated comparable quality, efficacy, safety, and immunogenicity to Eylea® in patients with neovascular (wet) age-related macular degeneration (nAMD).
Clinical Application and Disease Burden
The positive opinion covers the use of AHZANTIVE®/Baiama® for the treatment of adult patients with nAMD, diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularization (CNV), and macular edema following retinal vein occlusion (RVO). These conditions represent a significant burden on public health, with nAMD being a leading cause of vision loss in individuals over 60. DME is a common complication of diabetes and can also lead to significant visual impairment. The availability of a biosimilar offers a potentially more affordable treatment option for these prevalent conditions.
Comparative Efficacy and Safety
The clinical trials supporting the CHMP's positive opinion demonstrated that FYB203 exhibits comparable efficacy and safety profiles to the reference product, Eylea®. This is crucial for biosimilar approval, as it ensures that patients can receive a treatment option that is as effective and safe as the original biologic drug. The comprehensive data package included rigorous testing to confirm the biosimilarity in terms of quality, non-clinical attributes, and clinical performance.
Next Steps
Following the CHMP recommendation, the European Commission is expected to make a final decision regarding marketing authorization in the second half of January 2025. If approved, AHZANTIVE®/Baiama® will provide a new treatment option for patients across the EU suffering from retinal diseases, potentially reducing healthcare costs and increasing access to essential therapies.
