FDA accepts application for ranibizumab biosimilar

Biosimilares/Novedades | Posted 27/11/2020 post-comment0 Post your comment

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) and partner US biotechnology company Biogen announced on 18 November 2020 that the US Food and Drug Administration (FDA) had accepted the application for their proposed ranibizumab biosimilar (SB11).

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SB11 is a proposed biosimilar of blockbuster wet age-related macular degeneration (AMD) treatment Lucentis (ranibizumab) marketed by Genentech (Roche)/Novartis. In 2019, Lucentis had net sales of US$4 billion [1].

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 [2].

Hee Kyung Kim, Senior Vice President and Clinical Sciences Division and Regulatory Affairs Team Leader at Samsung Bioepis, said that the acceptance by FDA of the application for SB11 brings the company ‘a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders’.

Samsung Bioepis also had its application for SB11 accepted for review by the European Medicines Agency (EMA) in October 2020 [3]. The company already has three anti-tumour necrosis factor (TNF) biosimilars developed by Samsung Bioepis and commercialized by Biogen in Europe. Benepali (etanercept) was approved in January 2016, Flixabi (infliximab) in May 2016 and Imraldi (adalimumab) in August 2017 [4].

Samsung Bioepis initially made a deal with Biogen for biosimilars back in 2011 [5]. Then in November 2019 the company announced that it had expanded this deal to include two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in Australia, Canada, Europe, Japan and the US [6].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-ranibizumab 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab 
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for ranibizumab biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-ranibizumab-biosimilar-from-Samsung-Bioepis
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Samsung makes biosimilars deal with Biogen Idec [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Samsung-makes-biosimilars-deal-with-Biogen-Idec
6. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis expands biosimilars agreement with Biogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-expands-biosimilars-agreement-with-Biogen 

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Source: Biogen, Samsung Bioepis

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