EMA accepts application for bevacizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 26/07/2019 post-comment0 Post your comment

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 19 July 2019 that the application for approval for its proposed bevacizumab biosimilar SB8 has been accepted for review by the European Medicines Agency (EMA).

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Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Samsung Bioepis submitted its marketing application for SB8 to EMA in June 2019, following the completion, in October 2018, of a phase III trial for SB8 in lung cancer patients [1]. The company intends to present the results of this phase III trial for SB8 at the European Society for Medical Oncology in September 2019.

SB8 is the second anticancer biosimilar developed by Samsung Bioepis and will mark the fifth biosimilar that the company has had approved in Europe. The company gained European approval for Benepali (etanercept), Flixabi (infliximab), Imraldi (adalimumab) and Ontruzant in January 2016, May 2016, August 2017 and November 2017, respectively [2]. If approved, SB8 will be commercialized in Europe by MSD, which is known as Merck in Canada and the US.

Samsung Bioepis is also collaborating with 3SBio for copy biologicals of bevacizumab in China [3].

Other biosimilars that Samsung Bioepis has in development include SB11 (ranibizumab), which is currently undergoing a phase III trial in 705 patients with neovascular age-related macular degeneration and SB12 (eculizumab), which recently completed a phase I clinical trial in 240 healthy volunteers.

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1. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis starts phase III trial for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-starts-phase-III-trial-for-bevacizumab-biosimilar 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis makes deals for copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-makes-deals-for-copy-biologicals-in-China 

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Source: ClinicalTrials.gov, Korea Biomedical Review, Samsung Bioepis

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