EU guidelines for biosimilars Posted 08/10/2010

Last update: 7 November 2014

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 centralised 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
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) EMA/CHMP/BWP/247713/2012
Effective date: 1 December 2014
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: nonclinical and clinical issues EMEA/CHMP/BMWP/42832/2005
Effective date: 1 June 2006
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf

2. Revisions to overarching guidelines
EMA has the following draft guidelines under public consultation to develop revised guidelines for the overarching biosimilars guidelines:

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues EMEA/CHMP/BMWP/42832/2005 Rev. 1

Date: 3 June 2013
End of consultation (deadline for comments): 30 November 2013
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf

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

Recombinant erythropoietins EMEA/CHMP/BMWP/301636/2008
Effective date: 1 October 2010
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdf

Recombinant G-CSF EMEA/CHMP/BMWP/31329/2005
Effective date: 1 June 2006
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003955.pdf

Recombinant human insulin EMEA/CHMP/BMWP/32775/2005
Effective date: 1 June 2006
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003957.pdf

Low molecular weight heparins EMEA/CHMP/BMWP/118264/2007
Effective date: October 2009
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003927.pdf

Somatropin EMEA/CHMP/BMWP/94528/2005
Effective date: 1 June 2006
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003956.pdf

Recombinant interferon alfa EMEA/CHMP/BMWP/102046/2006
Effective date: April 2009
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003930.pdf

Monoclonal antibodies EMA/CHMP/BMWP/403543/2010
Effective date: 1 December 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/11/WC500099361.pdf

Interferon beta EMA/CHMP/BMWP/652000/2010
Effective date: 1 September 2013
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139622.pdf

Recombinant r-hFSH EMA/CHMP/BMWP/671292/2010
Effective date: 1 September 2013
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139624.pdf

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

Revision of guideline on recombinant human insulin EMA/CHMP/BMWP/506470/2011
End of consultation: 30 June 2013
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/12/WC500136392.pdf

Revision of guideline on low molecular weight heparins EMEA/CHMP/BMWP/118264/2007 Rev. 1
End of consultation: 31 July 2013
www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500138309&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc

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

Comparability of biotechnological/biological products ICH Topic Q 5 E CPMP/ICH/5721/03
Effective date: June 2005
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002805.pdf

Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues EMEA/CHMP/BMWP/101695/2006
Effective date: 1 November 2007
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003935.pdf

Immunogenicity assessment of biotechnology-derived therapeutic proteins EMEA/CHMP/BMWP/14327/2006
Effective date: April 2008
www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf

Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMEA/CHMP/BMWP/86289/2010
Effective date: 1 December 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/11/WC500099362.pdf

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

Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development EMA/297149/2013
Date: 28 June 2013
End of consultation: 31 September 2013
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144945.pdf

Concept paper on the revision of the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
CHMP/BMWP/42832/2005
Date: 20 February 2014
End of consultation: 30 June 2014
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/03/WC500163623.pdf

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Source: EMA

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