Home / Guidelines / EU guidelines for biosimilars

EU guidelines for biosimilars Posted 08/10/2010

Last update: 31 July 2015

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

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

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 EMEA/CHMP/BMWP/301636/2008
Effective date: 1 October 2010

Recombinant G-CSF EMEA/CHMP/BMWP/31329/2005
Effective date: 1 June 2006

Recombinant human insulin EMEA/CHMP/BMWP/32775/2005
Effective date: 1 June 2006

Low molecular weight heparins EMEA/CHMP/BMWP/118264/2007
Effective date: October 2009

Somatropin EMEA/CHMP/BMWP/94528/2005
Effective date: 1 June 2006

Recombinant interferon alfa EMEA/CHMP/BMWP/102046/2006
Effective date: April 2009

Monoclonal antibodies EMA/CHMP/BMWP/403543/2010
Effective date: 1 December 2012

Interferon beta EMA/CHMP/BMWP/652000/2010
Effective date: 1 September 2013

Recombinant r-hFSH EMA/CHMP/BMWP/671292/2010
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

4. 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

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

Immunogenicity assessment of biotechnology-derived therapeutic proteins EMEA/CHMP/BMWP/14327/2006
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 concept papers under public consultation to develop reflection papers or for revision of guidelines relevant for biosimilars:

Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor
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 EMA/297149/2013
Date: 28 June 2013
End of consultation: 31 September 2013

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

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

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 © 2013 Pro Pharma Communications International. All Rights Reserved.

Source: EMA

Comments (0)

Generics News Research General


Biosimilars News Research General