Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

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Current effective version

Revision 1 - Adopted guideline

Reference numberEMEA/CHMP/BMWP/42832/2005 Rev. 1
Published09/01/2015
Effective from01/07/2015
KeywordsSimilar biological medicinal product, recombinant proteins, non-clinical studies, clinical studies, safety, pharmacovigilance, immunogenicity
DescriptionThis document lays down the non-clinical and clinical requirements for a similar biological medicinal product. It provides guidance on the pharmaco-toxicological assessment, the requirements for pharmacokinetic, pharmacodynamic, and efficacy studies, clinical safety studies, including immunogenicity, as well as the risk management plan.


Document history

Revision 1

Current version

Overview of comments


Adopted guideline


Draft guideline


Concept paper

Published: 19/03/2018


In operation: 01/07/2015–present


Published: 10/06/2013


Published: 03/10/2011

First versionAdopted guidelineIn operation: 01/06/2006–30/06/2015


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