The regulatory body for approval of medicines in the EU is 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
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
Concept paper on the revision of the guideline on similar biological medicinal product
Date: 17 November 2011
End of consultation (deadline for comments): 29 February 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500117987.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
4. Draft Specific Guidelines
EMA has the following draft guidelines under public consultation to develop guidelines for specific biosimilar products:
Recombinant interferon beta EMA/CHMP/BMWP/652000/2010
End of consultation: 31 May 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120652.pdf
5. Concept papers for specific guidelines
EMA has the following concept papers to develop guidelines for specific biosimilar products in the pipeline in a draft form:
Recombinant follicle stimulation hormone EMA/CHMP/BMWP/94899/2010
Deadline for comments: 1 June 2010
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089208.pdf
Revision of guideline on low molecular weight heparins EMA/CHMP/BMWP/522386/2011
Deadline for comments: 30 September 2011
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109588.pdf
Revision of guideline on recombinant human insulin EMA/CHMP/BMWP/506470/2011
Deadline for comments: 30 September 2011
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/07/WC500109587.pdf
6. 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 forin vivoclinical 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
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
Source: www.gabionline.net
