Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Scientific guideline
This 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.
Keywords: Similar biological medicinal product, recombinant proteins, non-clinical studies, clinical studies, safety, pharmacovigilance, immunogenicity
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1 (PDF/164.72 KB)
Adopted
First published: 09/01/2015
Last updated: 09/01/2015
Legal effective date: 01/07/2015
EMEA/CHMP/BMWP/42832/2005 Rev1 -
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Overview of comments received on 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues' (EMEA/CHMP/BMWP/42832/2005 Rev. 1) (PDF/1.95 MB)
First published: 19/03/2018
Last updated: 19/03/2018
EMA/CHMP/772616/2013 -
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Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (PDF/161.89 KB)
Draft: consultation closed
First published: 10/06/2013
Last updated: 10/06/2013
Consultation dates: 10/06/2013 to 30/11/2013
EMEA/CHMP/BMWP/42832/2005 Rev. 1 -
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Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (PDF/141.53 KB)
Draft: consultation closed
First published: 03/10/2011
Last updated: 03/10/2011
Consultation dates: 22/09/2011 to 31/12/2011
EMA/CHMP/BMWP/572828/2011