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Clinical trials of biosimilars should become more similar
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  1. Jonathan Kay1,
  2. John D Isaacs2
  1. 1Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA
  2. 2Musculoskeletal Research Group, Institute of Cellular Medicine, Newcastle University and National Institute of Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne, UK
  1. Correspondence to Professor Jonathan Kay, Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Memorial Campus, 119 Belmont Street, Worcester, MA 01605, USA; jonathan.kay{at}umassmemorial.org

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Since the approval of the infliximab biosimilar, CT-P13, by the Korean Ministry of Food & Drug Safety (MFDS) on 23 July 2012,1 biosimilars to treat inflammatory diseases have become available to patients in many countries around the world.2 The European Commission (EC) approved CT-P13 on 10 September 2013,3 and, subsequently, it has been granted marketing authorisation by regulatory agencies in many other countries, including the USA. CT-P13 is now marketed in >70 countries worldwide as Remsima, Inflectra and Flammegis.4

Several other biosimilars of tumour necrosis factor (TNF) inhibitors have also received regulatory approval and are commercially available. HD203 was the first etanercept biosimilar granted marketing authorisation by the Korean MFDS on 11 November 2014 and was marketed as Davictrel in South Korea.5 However, because the facility where it was manufactured was sold, its licence could not be retained and it was withdrawn from the market upon the request of its manufacturer on 30 September 2015. Another etanercept biosimilar, SB4, which received approval by the Korean MFDS on 8 September 2015 and by the EC on 14 January 2016, is marketed as Brenzys in South Korea and as Benepali in the European Union (EU) and in the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.5 ,6 SB2, another infliximab biosimilar, was granted marketing authorisation by the Korean MFDS on 4 December 2015 and by the EC on 26 May 2016, and is sold as Renflexis in South Korea and as Flixabi in the EU and EEA member states.5 ,7 In this issue, Bae et al8 report the results of the phase III clinical trial of HD203 (etanercept biosimilar), Emery and colleagues report the results of the phase III clinical trial of SB4 (etanercept biosimilar)9 and Choe et …

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