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
Effective date: 30 October 2005
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: quality issues EMEA/CHMP/BWP/49348/2005
Effective date: 1 June 2006
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.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 concept papers to develop revised guidelines for biosimilar products in the pipeline in a draft form:

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues EMA/CHMP/BMWP/572828/2011
End of consultation (deadline for comments): 31 October 2011
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/10/WC500115611.pdf

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues EMA/CHMP/BWP/617111/2010
End of consultation (deadline for comments): 31 May 2011
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/02/WC500102285.pdf

Draft guideline on similar biological medicinal products
Date: 2 May 2013
End of consultation (deadline for comments): 31 October
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)
Start of public consultation date: 31 May 2012
End of consultation: 30 Nov 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf
Once finalised, this guideline will replace 'The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005)'.

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 alpha 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
http://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
http://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/biologicalproductsICH 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

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