Multidisciplinary: Biosimilar

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This page lists the European Medicines Agency's scientific guidelines on biosimilar medicines.

If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines.

Table of contents

Overarching biosimilar guidelines

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Similar biological medicinal products

Draft guideline

Concept paper

CHMP/437/04 Rev. 1

Released for consultation May 2013 Deadline for comments 31 October 2013
Similar biological medicinal productsAdopted guidelineCHMP/437/04September 2005October 2005 
Revision of the guideline on  immunogenicity assessment of biotechnology-derived  therapeutic proteinsConcept paperEMA/275542/2013Released for consultation March 2014 Deadline for comments 30 June 2014
Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Draft guideline

Concept paper

EMEA/CHMP/BMWP/42832/2005 Rev. 1Released for consultation June 2013 Deadline for comments 30 Nov 2013
Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issuesAdopted guidelineEMEA/CHMP/BMWP/42832/2005February 2006June 2006 
Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues

Draft guideline

Concept paper

EMA/CHMP/BWP/247713/2012Released for consultation May 2012 Deadline for comments 30 November 2012
Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issuesAdopted guidelineEMEA/CHMP/BWP/49348/2005February 2006June 2006 

Product-specific biosimilar guidelines

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Similar biological medicinal products containing recombinant follicle-stimulating hormone

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/BMWP/671292/2010March 20131 September 2013 
Similar biological medicinal products containing interferon beta

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/BMWP/652000/20100March 20131 September 2013 
Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/BMWP/403543/2010June 20121 December 2012 
Similar biological medicinal products containing recombinant erythropoietins

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/BMWP/301636/08April 201030 September 2010 
Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant erythropoietins

Submission of comments

Adopted guideline

EMEA/CHMP/945626/2005March 2006July 2006Superseded by EMEA/CHMP/BMWP/301636/08
Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

Draft guideline

Concept paper

EMEA/CHMP/BMWP/118264/2007 Rev. 1Released for consultation January 2013 Deadline for comments 31 July 2013
Similar biological medicinal products containing low-molecular-weight heparins

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/BMWP/118264/2007April 2009October 2009 
Non-clinical and clinical development of similar medicinal products containing recombinant interferon alpha

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/BMWP/102046/2006June 2009April 2009 
Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on biosimilar medicinal products containing recombinant granulocyte-colony stimulating factorAdopted guidelineEMEA/CHMP/BMWP/31329/2005February 2006June 2006 
Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing somatropinAdopted guidelineEMEA/CHMP/BMWP/94528/2005February 2006June 2006 
Revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

Draft guideline

Concept paper

EMEA/CHMP/BMWP/32775/2005Released for consultation December 2012 Deadline for comments 30 June 2013
Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guidance on similar medicinal products containing recombinant human insulinAdopted guidelineEMEA/CHMP/BMWP/32775/2005February 2006June 2006 

Other guidelines relevant for biosimilars

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/BMWP/86289/2010June 20121 December 2012 
Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/BMWP/101695/2006July 2007November 2007 
Immunogenicity assessment of biotechnology-derived therapeutic proteins

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/BMWP/14327/2006January 2008April 2008 
Comparability of medicinal products containing biotechnology-derived proteins as active substance - Quality issuesAdopted guidelineCPMP/ICH/5721/03December 2003December 2003Superseded by CPMP/ICH/5721/03
Comparability of medicinal products containing biotechnology-derived proteins as drug substance: non-clinical and clinical issuesAdopted guidelineEMEA/CPMP/3097/02December 2003June 2004Superseded by CHMP/BMWP/101695/06
Development of a Committee for Proprietary Medicinal Products guideline on comparability of biotechnology-derived productsConcept paperCPMP/BWP/1113/98June 1998