Similar biological medicinal products
| Current effective version | |
| Reference number | CHMP/437/04 Rev. 1 |
| Published | 29/10/2014 |
| Effective from | 30/04/2015 |
| Keywords | Similar biological medicinal product, biosimilar, biosimilarity exercise, comparability exercise, reference medicinal product, biosimilarity |
| Description | This 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 | In operation: 30/04/2015–present Published: 02/12/2014 Published: 02/05/2013 Published: 24/11/2011 | |
| First version |
 Adopted guideline
| In operation: 30/10/2005–29/04/2015 |
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