Similar biological medicinal products containing interferon beta

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/BMWP/652000/2010
Published06/03/2013
Effective from01/09/2013
KeywordsInterferon beta, similar biological medicinal product, biosimilar, comparability, non-clinical studies, clinical studies
DescriptionThis document lays down the non-clinical and clinical requirements for interferon beta (IFN-β) containing medicinal products claiming to be similar to another interferon beta already marketed.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/09/2013–present


Published: 06/03/2013


Published: 19/01/2012


Published: 06/04/2010


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