This document lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).
Keywords: Recombinant human insulin, insulin analogues, similar biological medicinal products, biosimilar, comparability, non-clinical studies, clinical studies, hyperinsulinaemic euglycaemic clamp, glucose clamp
Current effective version
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Revision 1
This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).
English (EN) (142.98 KB - PDF)
Document history - Revision 1 (current version)
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Revision 1
This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).
English (EN) (142.98 KB - PDF)
Overview of comments received on 'Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues'
Overview of comments
English (EN) (255.89 KB - PDF)
Second draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
This guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing products, including human insulin and insulin analogues (both referred to as insulin), claiming to be similar to another one already authorised (the reference medicinal product).
English (EN) (157.11 KB - PDF)
First draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
This guideline lays down the non-clinical and clinical requirements for recombinant insulin containing products, including human insulin and insulin analogues, claiming to be similar to another one already marketed.
The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section
addresses the requirements for pharmacokinetic, pharmacodynamic and safety studies as well as the risk management plan.
English (EN) (104.45 KB - PDF)
Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin
The current Guidance on Similar Medicinal Products containing Recombinant Human Insulin provides
recommendations for the development of recombinant soluble (short-acting) human insulin claimed to be similar to a reference product already authorised in the EU. This guideline came into effect in June 2006 but, so far, no biosimilar insulin has been licensed in the EU. Three products applied for by the same Applicant were withdrawn prior to Opinion.
English (EN) (248.45 KB - PDF)
Document history - First version
Annex to guideline on similar biological medicinal products containing Biotechnology-derived proteins as active substance: Non-clinical and clinical issues Guidance on similar medicinal products containing recombinant ...
English (EN) (101.57 KB - PDF)
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