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

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Download document Second draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
Reference number EMEA/CHMP/BMWP/32775/2005 Rev. 1
Status draft: consultation closed
First published 2014-04-30
Last updated 2014-04-30

Summary

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).