Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Scientific guideline

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

AdoptedReference Number: EMEA/CHMP/BMWP/32775/2005 Rev. 1Summary:

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).

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

AdoptedReference Number: EMEA/CHMP/BMWP/32775/2005 Rev. 1Summary:

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).

Overview of comments received on 'Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues'

Reference Number: EMA/674663/2014Summary:

Overview of comments

Second draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

Draft: consultation closedConsultation dates: 30/04/2014 to 31/07/2014Reference Number: EMEA/CHMP/BMWP/32775/2005 Rev. 1Summary:

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).

First draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues

Draft: consultation closedConsultation dates: 14/12/2012 to 30/06/2013Reference Number: EMEA/CHMP/BMWP/32775/2005 Rev. 1Summary:

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.

Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin

Draft: consultation closedConsultation dates: 21/07/2011 to 30/09/2011Reference Number: EMA/CHMP/BMWP/506470/2011Summary:

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.

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 ...

AdoptedReference Number: EMEA/CHMP/BMWP/32775/2005Legal effective date: 01/06/2006