EU Biosimilar Approvals To November 2015

Source: European Medicines Agency, European Public Assessment Reports.

Product	Company	Authorization Date	Reference Drug
Omnitrope (somatropin)	Sandoz	Apr 2006	Genotropin (Pfizer)
Binocrit (epoetin alfa)	Sandoz	Aug 2007	Eprex/Erypo (J&J)
Epoetin alfa Hexal	Hexal	Aug 2007	Eprex/Erypo
Abseamed (epoetin alfa)	Medice	Aug 2007	Eprex/Erypo
Silapo (epoetin zeta)	Stada	Dec 2007	Eprex/Erypo
Retacrit (epoetin zeta)	Hospira	Dec 2007	Eprex/Erypo
Biograstim (filgrastim)	CT Arzneimittel	Sept 2008	Neupogen/Amgen
Tevagrastim (filgrastim)	Teva	Sept 2008	Neupogen
Ratiograstim (filgrastim)	Ratiopharm	Sept 2008	Neupogen
Filgrastim Hexal	Hexal	Feb 2009	Neupogen
Zarzio (filgrastim)	Sandoz	Feb 2009	Neupogen
Nivestim (filgrastim)	Hospira	June 2010	Neupogen
Inflectra (infliximab)	Hospira	Sept 2013	Remicade/J&J
Remsima (infliximab)	Celltrion	Sept 2013	Remicade
Ovaleap (follitropin alfa)	Teva	Sept 2013	Gonal-F/Merck Serono
Grastofil (filgrastim)	Apotex/Stada	Oct 2013	Neupogen
Bemfola (follitropin alfa)	Finox Biotech	Mar 2014	Gonal-F
Abasaglar (insulin glargine)*	Lilly/BI	Sept 2014	Lantus/Sanofi
Accofil (filgrastim)	Accord Healthcare	Sept 2014	Neupogen
* The product's name was changed from Abasria in December 2014.

Sandoz' Biosimilar Etanercept On Its Way To EU Market