Biosimilars approved in Europe

August 15, 2011 10:20 AM

The legal framework to approve biosimilar products came into force in 2003 in the EU. With this framework, biosimilars can only be approved centrally via the European Medicines Agency – EMA (previously EMEA).

After the legal framework came into force, EMA developed guidelines for the approval of biosimilars during 2005 to 2006 and established an abbreviated registration process for biosimilars.

Omnitrope was the first product approved in the EU as a biosimilar, in 2006. To date, the 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 below.

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 02/06/2009 Hexal AG
Filgrastim Ratiopharm filgrastim Neutropenia Hematopoietic Stem Cell Transplantation Cancer 15/09/2008

Withdrawn on 20 Apr 2011 

Ratiopharm GmbH
Nivestim filgrastim Hematopoietic Stem Cell Transplantation Cancer Neutropenia 06/08/2010 Hospira UK Ltd
Omnitrope somatropin Turner Syndrome Dwarfism
Pituitary Prader-Willi Syndrome
04/12/2006 Sandoz GmbH
Ratiograstim filgrastim Neutropenia
Hematopoietic Stem Cell Transplantation
Cancer
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
Blood Transfusion Autologous
Cancer Kidney Failure
18/12/2007 Stada R&D AG
Tevagrastim filgrastim Neutropenia Cancer
Hematopoietic Stem Cell Transplantation
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 02/06/2009 Sandoz GmbH

Although the approval speed for new biosimilars are getting lower in the two last years (only one new approval since June 2009), more to come with the patent expiries of monoclonal antibodies.

The draft guideline of monoclonal antibodies was released for public consultation in November 2010 and the deadline for comments was May 31st, 2011. Now, the final version is going to be published and with this new guideline, more biosimilars are expected within the EU. The draft version of the monoclonal antibodies guideline can be accessed from here:

 

Published: 15.08.2011
Updated: 06.07.2012

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