This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Section 4, Part II, Annex I to Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied

[for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’.


This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles of establishing biosimilarity.

Document details

Download document Draft guideline on similar biological medicinal products
Reference number CHMP/437/04 Rev. 1
Status draft: consultation open
First published 02/05/2013
Last updated 02/05/2013
Consultation start date 02/05/2013
Consultation end date 31/10/2013
Email address for submissions


Posted on the EMA website on 22 May 2013