bioeq’s second product FYB203 is a biosimilar of aflibercept (Eylea®)1 which was licensed by Santo Holding from Formycon AG in May 2015. Similarly to Lucentis®, Eylea® is prescribed for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions.The development program is backed up by continuous and close alignment via scientific meetings with both, the U.S. Food and Drug Administration (FDA), and the European Medicine Agency (EMA).
bioeq started a global pivotal Phase III clinical trial in August 2020. The objective of this study is to demonstrate comparable safety, efficacy and immunogenicity of FYB203 to Eylea® in patients with neovascular age-related maculat degeneration (nAMD). The introduction of FYB203 biosimilar to the market is anticipated in the U.S. in 2024 and in Europe in 2025.
1 Eylea is a registered trademark of Regeneron Inc.