Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

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Download document Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
Reference number EMEA/CHMP/BMWP/42832/2005 Rev. 1
Status draft: consultation closed
First published 10/06/2013
Last updated 10/06/2013

Summary

This guideline lays down the non-clinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed ('biosimilar').