Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues - Scientific guideline
Table of contents
This 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.
Keywords: Biosimilars, monoclonal antibodies, similar biological medicinal products, relevant animal model, non-clinical studies, in vitro studies, clinical use, clinical endpoints, extrapolation
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Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues (PDF/211.11 KB)
Adopted
First published: 15/06/2012
Last updated: 15/06/2012
Legal effective date: 01/12/2012
EMA/CHMP/BMWP/403543/2010 -
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Overview of comments received on 'guideline on similar biological medicinal products containing monoclonal antibodies' (EMA/CHMP/BMWP/403543/2010) (PDF/1.52 MB)
First published: 15/06/2012
Last updated: 15/06/2012
EMA/205886/2012 -
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Draft guideline on similar biological medicinal products containing monoclonal antibodies (PDF/194.94 KB)
Draft: consultation closed
First published: 26/11/2010
Last updated: 26/11/2010
Consultation dates: 18/11/2010 to 31/05/2011
EMA/CHMP/BMWP/403543/2010 -
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Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies (PDF/56.83 KB)
Draft: consultation closed
First published: 18/11/2009
Last updated: 18/11/2009
Consultation dates: 01/10/2009 to 31/01/2010
EMEA/632613/2009