EMA accepts application for ranibizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 23/10/2020 post-comment0 Post your comment

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.

Application V15a16

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 [1].

Ranibizumab [2] is an eye disease treatment, specifically for retinal vascular disorders, which are a leading cause of blindness. 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.

Samsung Bioepis and Biogen are collaborating to create SB11, a more affordable potential treatment option for patients with retinal vascular disorders. Through this, and the development of other biosimilars, they hope to facilitate healthcare sustainability and improve patient access to drugs and treatment globally.

The collaboration between the two companies sees biosimilar development by Samsung Bioepis and commercialization by Biogen. This commercialization agreement was announced in November 2019 [3] and surrounds the development and commercialization of two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in Australia, Canada, Europe, Japan and the US.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 23]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis expands biosimilars agreement with Biogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 23]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-expands-biosimilars-agreement-with-Biogen

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