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Table 3 EMA approved biosimilars (European Medicines Agency 2016)

From: Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region

Date of biosimilar EMA approval Biosimilar product Original product Active substance
12 April 2006 Omnitrope Genotropin Somatropin
28 August 2007 Abseamed Epogen/Eprex Epoetin alfa
28 August 2007 Binocrit Epogen/Eprex Epoetin alfa
28 August 2007 Epoetin Alfa Hexal Epogen/Eprex Epoetin alfa
18 December 2007 Silapo Epogen/Eprex Epoetin zeta
18 December 2007 Retacrit Epogen/Eprex Epoetin zeta
15 September 2008 Biograstim Neupogen Filgrastim
15 September 2008 Ratiograstim Neupogen Filgrastim
15 September 2008 Tevagrastim Neupogen Filgrastim
06 February 2009 Filgrastim Hexal Neupogen Filgrastim
06 February 2009 Zarzio Neupogen Filgrastim
08 June 2010 Nivestim Neupogen Filgrastim
10 September 2013 Inflectra Remicade Infliximab
27 September 2013 Ovaleap Gonal-f Follitropin alfa
10 October 2013 Remsima Remicade Infliximab
18 October 2013 Grastofil Neupogen Filgrastim
27 March 2014 Bemfola Gonal-f Follitropin alfa
09 September 2014 Abasaglar (previously Abasria) Lantus Insulin glargine
18 September 2014 Accofil Neupogen Filgrastim
14 January 2016 Benepali Enbrel Etanercept
26 May 2016 Flixabi Remicade Infliximab