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

Current effective version

PDF iconRevision 1 - Adopted guideline

Reference numberEMEA/CHMP/BMWP/42832/2005 Rev. 1
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

PDF iconOverview of comments

PDF iconAdopted guideline

PDF iconDraft guideline

PDF iconConcept paper

Published: 19/03/2018

In operation: 01/07/2015–present

Published: 10/06/2013

Published: 03/10/2011

First version PDF iconAdopted guideline In operation: 01/06/2006–30/06/2015

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