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Biosimilars approved in Europe Posted 08/07/2011

Last update: 10 May 2013

In the EU, a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via EMA and not nationally.

During 2005 to 2006, EMA developed guidelines for the approval of biosimilars via an abbreviated registration process.

Omnitrope (somatropin) was the first product approved in the EU as a biosimilar, in 2006 [1]. To date, EMA has approved 14 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor and erythropoietin, for use in the EU, see Table 1. Since then two biosimilar approvals have been withdrawn; one for filgrastim in April 2011 and one for somatropin in May 2012, leaving 12 biosimilars approved for use in Europe.

Table 1: EMA approved biosimilars*

Product Name	Active Substance	Therapeutic Area	Authorisation Date	Manufacturer/Company Name
Abseamed	epoetin alfa	Anaemia Cancer Chronic kidney failure	28 Aug 2007	Medice Arzneimittel Pütter GmbH & Co KG
Binocrit	epoetin alfa	Anaemia Chronic kidney failure	28 Aug 2007	Sandoz GmbH
Biograstim	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	15 Sep 2008	CT Arzneimittel GmbH
Epoetin alfa Hexal	epoetin alfa	Anaemia Cancer Chronic kidney failure	28 Aug 2007	Hexal AG
Filgrastim Hexal	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	6 Feb 2009	Hexal AG
Filgrastim ratiopharm	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	15 Sep 2008 Withdrawn on 20 Apr 2011	Ratiopharm GmbH
Nivestim	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	8 Jun 2010	Hospira UK Ltd
Omnitrope	somatropin	Pituitary dwarfism Prader-Willi syndrome Turner syndrome	12 Apr 2006	Sandoz GmbH
Ratiograstim	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	15 Sep 2008	Ratiopharm GmbH
Retacrit	epoetin zeta	Anaemia Autologous blood transfusion Cancer Chronic kidney failure	18 Dec 2007	Hospira UK Ltd
Silapo	epoetin zeta	Anaemia Autologous blood transfusion Cancer Chronic kidney failure	18 Dec 2007	Stada R & D AG
Tevagrastim	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	15 Sep 2008	Teva Generics GmbH
Valtropin	somatropin	Pituitary dwarfism Turner syndrome	24 Apr 2006 Withdrawn on 10 May 2012	BioPartners GmbH
Zarzio	filgrastim	Cancer Haematopoietic stem cell transplantation Neutropenia	6 Feb 2009	Sandoz GmbH

*Data collected on 12 May 2011, updated on 7 May 2013
Source: EMA

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars use in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 10]. Available from: www.gabionline.net/Reports/Biosimilars-use-in-Europe

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Source: EMA

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