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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
Guideline on similar biological medicinal products
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues
2. Specific Guidelines
Recombinant erythropoietins
Recombinant G-CSF
Low molecular weight heparins
Somatropin
Recombinant interferon alfa
Monoclonal antibodies
Interferon beta
Recombinant r-hFSH
Human insulin EMEA
3. Draft Specific Guidelines
Revision of guideline on low molecular weight heparins
Revision of guideline on interferon alfa
4. Other guidelines
Comparability of biotechnological/biological products ICH Topic Q 5 E
Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues
Immunogenicity assessment of biotechnology-derived therapeutic proteins
Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMEA/CHMP/BMWP/86289/2010
5. Draft other guidelines
Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
Concept paper on the revision of the guideline on recombinant G-CSF
Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Related articles 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 Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.
These guidelines cover all biosimilar 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
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
EMEA/CHMP/BMWP/42832/2005 Rev1
Effective date: 1 July 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf
These guidelines are specific to the type of biosimilar product:
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
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
EMEA/CHMP/BMWP/118264/2007
Effective date: October 2009
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003927.pdf
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
EMEA/CHMP/BMWP/102046/2006
Effective date: April 2009
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003930.pdf
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
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
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
CHMP/BMWP/32775/2005_Rev. 1
Effective date: 1 September 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdf
EMA has the following draft guidelines under public consultation to develop guidelines for specific biosimilar products:
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
Date: 4 January 2016
End of consultation: 31 March 2016
www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500199346&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc
Other guidelines relevant for biosimilars from EMA include:
CPMP/ICH/5721/03
Effective date: June 2005
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002805.pdf
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
EMEA/CHMP/BMWP/14327/2006
Effective date: April 2008
www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf
Effective date: 1 December 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/11/WC500099362.pdf
EMA has the following drafts or concept papers under public consultation to develop reflection papers or for revision of guidelines relevant for biosimilars:
EMEA/CHMP/BMWP/14327/2006 Rev. 1
Date: 24 September 2015
End of consultation: 31 January 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500194507.pdf
EMA/CHMP/BMWP/214262/2015
Date: 27 July 2015
End of consultation: 31 October 2015
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/07/WC500190635.pdf
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
EMA to revise overarching biosimilar guidelines
Source: EMA
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