FYB201

bioeq’s lead product, FYB201, is a biosimilar version of the blockbuster ophthalmology drug ranibizumab (Lucentis®)1 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), and other serious eye conditions.The development program is backed up by continuous and close alignment via scientific advice meetings with both, the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA). A global pivotal Phase III clinical trial completed in 2018 demonstrated comparable safety, efficacy and immunogenicity of FYB201 to Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The results of the study were accepted for publication by the American Academy of Ophthalmology and are available online2.

bioeq has submitted marketing authorization applications (MAA) for FYB201 to the European Medicines Agency (EMA) in June 2021 and to the UK MHRA in July 2021. The commercialization of FYB201 in Europe, Canada, Isreael and New Zealand will be performed by Teva Pharmaceutical Industries Ltd. ("Teva"), which has aquired the distribution rights under an exclusive strategic partnership from bioeq. In 2019 bioeq had already entered into a license and development agreement with the US Biosimilar-specialist Coherus BioSciences Inc., which will exclusively distribute FYB201 in the United States of America (US). The introduction of FYB201 biosimilar to the market is anticipated in the U.S. and in Europe in 2022.

 

1 Lucentis® is a registered trademark of Genentech Inc.

2 American Academy of Ophthalmology: Efficacy and Safety of Biosimilar FYB201 compared with Ranibizumab in Neovascular Age-Related Macular Degeneration, published May 02, 2021