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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