The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen.
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 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.
It was announced on 25 June 2021, that the CHMP had adopted a positive opinion for Byooviz (SB11), a biosimilar of ranibizumab produced by Samsung Bioepis and Biogen. The Committee recommended approval of Byooviz for the treatment of wet age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion, and visual impairment due to choroidal neovascularization.
The recommendation is based on a phase III clinical trial showing equivalent efficacy to the originator product. Improvements in primary efficacy outcomes remained stable and were equivalent between treatment groups at all time points. The opinion will be referred to the European Commission to grant marketing authorization for the product.
Kyung-Ah Kim, Senior Vice President and Development Division at Samsung Bioepis, said: ‘We are very proud to see Byooviz becoming the first biosimilar of ranibizumab to be recommended for approval in Europe. This marks an important milestone for our company, as this is one step forward to expanding patient access to treatments for retinal vascular disorders’.
Ian Henshaw, Global Head of Biosimilars at Biogen, added: ‘Retinal vascular disorders affect millions of people, and we believe Byooviz has the potential to be a meaningful therapeutic offering for patients living with these disorders. Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases’.
An application for Byooviz (SB11) was accepted by the US Food and Drug Administration in November 2020 . Samsung Bioepis and Biogen have worked together previously on three other biosimilars: Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab) .
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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/biosimilars/news/FDA-accepts-application-for-ranibizumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis expands biosimilars agreement with Biogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 16]. Available from: www.gabionline.net/pharma-news/Samsung-Bioepis-expands-biosimilars-agreement-with-Biogen
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