Draft guideline on similar biological medicinal products

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Download document Draft guideline on similar biological medicinal products
Reference number CHMP/437/04 Rev. 1
Status draft: consultation closed
First published 02/05/2013
Last updated 02/05/2013

Summary

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.