FYB201

bioeq’s lead product, FYB201, is a biosimilar version of the blockbuster ophthalmology drug ranibizumab (Lucentis®) and is being developed in collaboration with bioeq’s license partner Formycon AG. Ranibizumab is a humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A). It is indicated for the 'wet' form of age-related macular degeneration (AMD), other sight problems associated with choroidal neovascularization (abnormal growth of blood vessels beneath the retina); macular oedema caused by diabetes and macular oedema caused by occlusion of the veins behind the retina. The project has received favourable scientific advice from both the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regarding the preclinical and clinical development program and based on this important milestone bioeq and Formycon AG started a global pivotal Phase III clinical trial in December 2015. The objective of this study is to demonstrate comparable safety, efficacy and immunogenicity of FYB201 to Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The introduction of the FYB201 biosimilar to the market is anticipated in the U.S. in 2020 and in Europe in 2022. The expected global market size for ranibizumab in 2020 is estimated to be 2.5 bn USD (Evaluate Ltd, 2016).