Similar biological medicinal products
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
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Guideline on similar biological medicinal products (Rev.1) (PDF/120.46 KB)
Adopted
First published: 29/10/2014
Last updated: 29/10/2014
Legal effective date: 30/04/2015
CHMP/437/04 Rev.1 -
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Overview of comments received on draft guideline on similar biological medicinal products (PDF/1.26 MB)
First published: 02/12/2014
Last updated: 02/12/2014
EMA/748294/2013 -
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Draft guideline on similar biological medicinal products (PDF/117.65 KB)
Draft: consultation closed
First published: 02/05/2013
Last updated: 02/05/2013
Consultation dates: 02/05/2013 to 31/10/2013
CHMP/437/04 Rev. 1 -
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Concept paper on the revision of the guideline on similar biological medicinal product (PDF/136.67 KB)
Draft: consultation closed
First published: 24/11/2011
Last updated: 24/11/2011
Consultation dates: 17/11/2011 to 29/02/2012
EMA/CHMP/BMWP/572643/2011