Formycon AG has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its aflibercept biosimilar, FYB203, which will be marketed as AHZANTIVE®/Baiama®. This decision paves the way for potential European Union market approval for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and other retinal diseases.
The CHMP's positive opinion is based on a comprehensive review of analytical, pre-clinical, clinical, and manufacturing data. The data demonstrated that FYB203 is biosimilar to the reference product, Eylea® (aflibercept), with equivalent quality, efficacy, and safety profiles. This rigorous assessment supports the biosimilar's potential as a cost-effective alternative for patients requiring aflibercept treatment.
Clinical Equivalence
The clinical program included studies designed to demonstrate comparability between FYB203 and Eylea. These studies assessed key parameters such as best-corrected visual acuity (BCVA) and central retinal thickness (CRT), primary endpoints for assessing efficacy in nAMD. Detailed results from these studies have not been released, but the CHMP's positive opinion suggests that the data met the stringent requirements for biosimilar approval, demonstrating no clinically meaningful differences between FYB203 and Eylea.
Anticipated Market Authorization
Following the positive CHMP opinion, the European Commission is expected to grant marketing authorization for FYB203 by January 2025. This approval would allow Formycon to market AHZANTIVE®/Baiama® throughout the European Union, providing a new treatment option for patients with nAMD and other retinal vascular disorders. The introduction of a biosimilar aflibercept is anticipated to increase patient access to this important therapy and potentially reduce healthcare costs.
Impact on Retinal Disease Treatment
Neovascular AMD is a leading cause of vision loss in individuals over the age of 50. It is characterized by the abnormal growth of blood vessels in the macula, the central part of the retina responsible for sharp, central vision. Current treatments, including anti-VEGF therapies like aflibercept, have significantly improved outcomes for patients with nAMD. The availability of biosimilars like FYB203 promises to further expand access to these life-changing treatments.
