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
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).
English (EN) (164.72 KB - PDF)
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
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).
English (EN) (164.72 KB - PDF)
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)
English (EN) (1.95 MB - PDF)
Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues
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').
English (EN) (161.89 KB - PDF)
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
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.
English (EN) (141.53 KB - PDF)
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
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.
English (EN) (141.53 KB - PDF)
Related content
- Multidisciplinary: biosimilar
- Directive 2001/83/EC
- Bioanalytical method validation
- Choice of a non-inferiority margin
- Clinical investigation of the pharmacokinetics of therapeutic proteins
- Good pharmacovigilance practices
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- Immunogenicity assessment of biotechnology-derived therapeutic proteins
- Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
- Similar biological medicinal products
- Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues