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 for its aflibercept biosimilar candidate, FYB203 (marketed as AHZANTIVE®/Baiama®). This decision paves the way for potential marketing authorization in the European Union (EU).
The positive CHMP opinion supports the use of FYB203 for treating 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 CHMP's recommendation is grounded in a comprehensive evaluation of analytical, pre-clinical, clinical, and manufacturing data. The data demonstrated that FYB203 exhibits comparable quality, efficacy, safety, and immunogenicity to the reference drug, Eylea® (aflibercept), in patients with nAMD. This comparability is crucial for biosimilar approval, ensuring patients receive a treatment option with similar clinical outcomes.
The European Commission is anticipated to make a final decision regarding marketing authorization in the second half of January 2025. If approved, FYB203 will offer a more affordable alternative to aflibercept, potentially increasing patient access to this important treatment.
"The positive CHMP opinion is a significant milestone for FYB203 and underscores its potential to provide a cost-effective treatment option for patients with serious retinal diseases," said Sabrina Müller, Director of Investor Relations and Corporate Communications at Formycon AG.
Impact on Ophthalmology
Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals over 50. The wet form, nAMD, is characterized by the growth of abnormal blood vessels under the retina, leading to rapid vision deterioration. Diabetic macular edema (DME) is another major cause of vision loss, affecting individuals with diabetes. Aflibercept, a VEGF (vascular endothelial growth factor) inhibitor, has become a standard treatment for these conditions, preventing blood vessel growth and reducing fluid leakage in the retina.
The current treatment landscape relies heavily on anti-VEGF therapies like aflibercept. The introduction of biosimilars like FYB203 aims to reduce the financial burden on healthcare systems and patients, while maintaining the same level of efficacy and safety. This positive opinion from CHMP is a crucial step towards achieving that goal.
Clinical Trial Data
The clinical development program for FYB203 included rigorous comparative studies to demonstrate biosimilarity to Eylea®. These studies assessed various parameters, including visual acuity, anatomical outcomes, and safety profiles. The results indicated no clinically meaningful differences between FYB203 and Eylea®, supporting the biosimilar designation.
About Formycon
Formycon AG is a biopharmaceutical company focused on developing and commercializing high-quality biosimilars. The company's pipeline includes biosimilars for various therapeutic areas, including ophthalmology, immunology, and oncology.
