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Biosimilars approved in Europe
Published: 2011-09-05
Last update: 11 October 2011
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 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 stimulating factor and erythropoietin, for use in the EU, see Table 1.
Table 1: EMA approved biosimilars*
| Product Name | Active Substance | Therapeutic Area | Authorisation Date | Manufacturer/Company Name |
| Abseamed | epoetin alfa | Kidney Failure Chronic Anemia Cancer | 28/08/2007 | Medice Arzneimittel Pütter GmbH & Co KG |
| Binocrit | epoetin alfa | Kidney Failure Chronic Anemia | 28/08/2007 | Sandoz GmbH |
| Biograstim | filgrastim | Hematopoietic Stem Cell Transplantation Neutropenia Cancer | 15/09/2008 | CT Arzneimittel GmbH |
| Epoetin alfa Hexal | epoetin alfa | Kidney Failure Chronic Anemia Cancer | 28/08/2007 | Hexal AG |
| Filgrastim Hexal | filgrastim | Neutropenia Cancer Hematopoietic Stem Cell Transplantation | 06/02/2009 | Hexal AG |
| Filgrastim Ratiopharm | filgrastim | Neutropenia Hematopoietic Stem Cell Transplantation Cancer |
15/09/2008 | Ratiopharm GmbH |
| Nivestim | filgrastim | Hematopoietic Stem Cell Transplantation Cancer Neutropenia | 08/06/2010 | Hospira UK Ltd |
| Omnitrope | somatropin |
Turner Syndrome Dwarfism | 12/04/2006 | Sandoz GmbH |
| Ratiograstim | filgrastim |
Neutropenia | 15/09/2008 | Ratiopharm GmbH |
| Retacrit | epoetin zeta | Hematopoietic Stem Cell Transplantation Cancer Neutropenia | 18/12/2007 | Hospira UK Limited |
| Silapo | epoetin zeta |
Chronic Anemia | 18/12/2007 | Stada R & D AG |
| Tevagrastim | filgrastim |
Neutropenia Cancer | 15/09/2008 | Teva Generics GmbH |
| Valtropin | somatropin | Dwarfism Pituitary Turner Syndrome | 24/04/2006 | BioPartners GmbH |
| Zarzio | filgrastim | Cancer Hematopoietic Stem Cell Transplantation Neutropenia | 06/02/2009 | Sandoz GmbH |
*Data collected on 12 May 2011
Source: www.gabionline.net
Last update: 2011-10-11 | 
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