Similar biological medicinal products

  • Email
  • Help
Current effective version

Revision 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

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


Related content


How helpful is this page?

Average rating:

 Based on 12 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
1 ratings
11 ratings
    

Tell us more