German-headquartered companies Formycon and Bioeq have announced a European marketing authorization application for their ranibizumab biosimilar, FYB201.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab .
Ranibizumab, sold under the brand name Lucentis, can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss .
On 29 June 2021, Formycon and their license partner Bioeq announced a marketing authorization application had been sent to the European Medicines Agency (EMA) for their biosimilar version of ranibizumab, currently known as FYB201.
Formycon and Bioeq began phase III clinical trials of the product in October 2015 . The trial confirmed biosimilarity in terms of safety, efficacy and immunogenicity of FYB201 compared to the originator product, Lucentis, in patients with neovascular age-related macular degeneration.
This follows the recent EMA positive opinion received by Samsung Bioepis and Biogen for their ranibizumab biosimilar, Byooviz .
Formycon will also submit a Biologics Licence Application (BLA) for FYB201 to the Food and Drug Administration (FDA) in the US, where patents on Lucentis have already expired. They face competition from Alteogen’s aflibercept biosimilar, which is also a VEGF inhibitor and can be used for the treatment of similar eye conditions .
Lastly, Teva Pharmaceutical Industries (Teva) has acquired distribution rights from Bioeq and will be responsible for commercialization of FYB201 in Europe once marketing authorization is granted .
Clinical trials for aflibercept biosimilars
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[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-samsung-bioepis-biogen-s-ranibizumab-biosimilar-byooviz
5. GaBI Online - Generics and Biosimilars Initiative. Advances for Formycon and Alteogen’s eye disease biosimilar candidates [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 3]. Available from:
6. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 3]. Available from: www.gabionline.net/pharma-news/teva-signs-deal-with-bioeq-for-ranibizumab-biosimilar-fyb201
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