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)

AdoptedReference Number: CHMP/437/04 Rev.1Legal effective date: 30/04/2015Summary:

This guideline 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 of establishing biosimilarity.

Document history - Revision 1 (current version)

Guideline on similar biological medicinal products (Rev.1)

AdoptedReference Number: CHMP/437/04 Rev.1Legal effective date: 30/04/2015Summary:

This guideline 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 of establishing biosimilarity.

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 closedConsultation dates: 02/05/2013 to 31/10/2013Reference Number: CHMP/437/04 Rev. 1

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

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

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

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