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

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Current effective versionRevision 1 - Adopted guideline
Reference numberEMEA/CHMP/BMWP/32775/2005 Rev. 1
Published11/03/2015
Effective from01/09/2015
KeywordsRecombinant human insulin, insulin analogues, similar biological medicinal products, biosimilar, comparability, non-clinical studies, clinical studies, hyperinsulinaemic euglycaemic clamp, glucose clamp
DescriptionThis 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).


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Second draft guideline


First draft guideline


Concept paper

In operation: 01/09/2015–present


Published: 07/04/2015


Published: 30/04/2014


Published: 14/12/2012


Published: 27/07/2011

First versionAdopted guidelineIn operation: 01/06/2006–01/09/2015


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