Non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha

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Current effective version

Reflection paper


Currently under revision - see below

Reference numberEMEA/CHMP/BMWP/102046/2006
Published23/04/2009
KeywordsRecombinant interferon alpha, similar biological medicinal products, biosimilar, non-clinical studies, clinical studies
DescriptionThis document lays down considerations on the non-clinical and clinical development of recombinant interferon alfa-containing medicinal products claiming to be similar to another such product already authorised.


Document history

Revision 1 

In progress

Concept paperPublished: 04/01/2016

First version

Current version

Reflection paper


Draft reflection paper


Concept paper

Published: 23/04/2009


Published: 18/10/2007


Published: 26/04/2006


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