Similar biological medicinal products

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberCHMP/437/04 Rev. 1
Published29/10/2014
Effective from30/04/2015
KeywordsSimilar biological medicinal product, biosimilar, biosimilarity exercise, comparability exercise, reference medicinal product, biosimilarity
DescriptionThis document outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars). It describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity.


Document history

Revision 1

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 30/04/2015–present


Published: 02/12/2014


Published: 02/05/2013


Published: 24/11/2011

First version PDF iconAdopted guideline In operation: 30/10/2005–29/04/2015


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