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

Current effective version

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/42832/2005 Rev1 Legal effective date: 01/07/2015 Summary:

This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues' (EMEA/CHMP/BMWP/42832/2005).

Document history - Revision 1 (current version)

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1

Adopted Reference Number: EMEA/CHMP/BMWP/42832/2005 Rev1 Legal effective date: 01/07/2015 Summary:

This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues' (EMEA/CHMP/BMWP/42832/2005).

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)

Reference Number: EMA/CHMP/772616/2013

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

Draft: consultation closed Consultation dates: 10/06/2013 to 30/11/2013 Reference Number: EMEA/CHMP/BMWP/42832/2005 Rev. 1 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').

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

Draft: consultation closed Consultation dates: 22/09/2011 to 31/12/2011 Reference Number: EMA/CHMP/BMWP/572828/2011 Summary:

The proposed guideline will replace the guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues: CHMP/BMWP/42832/2005.

Document history - First version

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

Draft: consultation closed Consultation dates: 22/09/2011 to 31/12/2011 Reference Number: EMA/CHMP/BMWP/572828/2011 Summary:

The proposed guideline will replace the guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues: CHMP/BMWP/42832/2005.