Similar biological medicinal products - Scientific guideline

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.

Keywords: Similar biological medicinal product, biosimilar, biosimilarity exercise, comparability exercise, reference medicinal product, biosimilarity

Current effective version

Guideline on similar biological medicinal products (Rev.1)

Adopted Reference Number: CHMP/437/04 Rev.1 Legal effective date: 30/04/2015

Document history - Revision 1 (current version)

Guideline on similar biological medicinal products (Rev.1)

Adopted Reference Number: CHMP/437/04 Rev.1 Legal effective date: 30/04/2015

Overview of comments received on draft guideline on similar biological medicinal products

Reference Number: EMA/748294/2013

Draft guideline on similar biological medicinal products

Draft: consultation closed Consultation dates: 02/05/2013 to 31/10/2013 Reference Number: CHMP/437/04 Rev. 1

Concept paper on the revision of the guideline on similar biological medicinal product

Draft: consultation closed Consultation dates: 17/11/2011 to 29/02/2012 Reference Number: EMA/CHMP/BMWP/572643/2011 Summary:

The proposed guideline will replace the guideline on Similar Biological Medicinal Products (CHMP/437/04).

Document history - First version

Guideline on similar biological medicinal products - First version

Adopted Reference Number: CHMP/437/04 Legal effective date: 30/10/2005