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EU guidelines for biosimilars Posted 08/10/2010

Last update: 8 January 2016

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure.

EMA has the following guidelines regarding biosimilars:

1. Overarching Guidelines
These guidelines cover all biosimilar products:

Guideline on similar biological medicinal products
CHMP/437/04 Rev 1
Effective date: 30 April 2015

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Effective date: 1 December 2014

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues
EMEA/CHMP/BMWP/42832/2005 Rev1
Effective date: 1 July 2015

2. Specific Guidelines
These guidelines are specific to the type of biosimilar product:

Recombinant erythropoietins
Effective date: 1 October 2010

Recombinant G-CSF
Effective date: 1 June 2006

Low molecular weight heparins
Effective date: October 2009

Effective date: 1 June 2006

Recombinant interferon alfa
Effective date: April 2009

Monoclonal antibodies
Effective date: 1 December 2012

Interferon beta
Effective date: 1 September 2013

Recombinant r-hFSH
Effective date: 1 September 2013

Human insulin EMEA
CHMP/BMWP/32775/2005_Rev. 1
Effective date: 1 September 2015

3. Draft Specific Guidelines
EMA has the following draft guidelines under public consultation to develop guidelines for specific biosimilar products:

Revision of guideline on low molecular weight heparins 
EMEA/CHMP/BMWP/118264/2007 Rev. 1
End of consultation: 31 July 2013

Revision of guideline on interferon alfa
Date: 4 January 2016
End of consultation: 31 March 2016

4. Other guidelines
Other guidelines relevant for biosimilars from EMA include:

Comparability of biotechnological/biological products ICH Topic Q 5 E
Effective date: June 2005

Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues
Effective date: 1 November 2007

Immunogenicity assessment of biotechnology-derived therapeutic proteins
Effective date: April 2008

Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMEA/CHMP/BMWP/86289/2010
Effective date: 1 December 2012

5. Draft other guidelines
EMA has the following drafts or concept papers under public consultation to develop reflection papers or for revision of guidelines relevant for biosimilars:

Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
EMEA/CHMP/BMWP/14327/2006 Rev. 1 
Date: 24 September 2015
End of consultation: 31 January 2015

Concept paper on the revision of the guideline on recombinant G-CSF
Date: 27 July 2015
End of consultation: 31 October 2015

Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Date: 28 June 2013
End of consultation: 31 September 2013

Related articles
EMA to revise overarching biosimilar guidelines

EMA adopts guideline on biosimilar monoclonal antibodies

The current EU regulatory framework governing biosimilars

Regulatory recommendations for biosimilars in the EU

EMA plans to revise biosimilar guidelines

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Source: EMA

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