Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BMWP/403543/2010
Published15/06/2012
Effective from01/12/2012
KeywordsBiosimilars, monoclonal antibodies, similar biological medicinal products, relevant animal model, non-clinical studies, in vitro studies, clinical use, clinical endpoints, extrapolation
DescriptionThis document lays down the non-clinical and clinical requirements for monoclonal antibody (mAb) containing medicinal products claiming to be similar to another one already authorised.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2012–present


Published: 15/06/2012


Published: 26/11/2010


Published: 17/11/2009


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