Similar biological medicinal products

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/437/04 Rev. 1
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

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 30/04/2015–present

Published: 02/12/2014

Published: 02/05/2013

Published: 24/11/2011

First versionAdopted guidelineIn operation: 30/10/2005–29/04/2015

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