Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues - Scientific guideline
HumanScientific guidelines
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
Current effective version
Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
AdoptedLegal effective date: Reference Number: EMA/CHMP/BMWP/403543/2010
English (EN) (211.11 KB - PDF)
First published: Last updated:
Document history
Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
AdoptedLegal effective date: Reference Number: EMA/CHMP/BMWP/403543/2010
English (EN) (211.11 KB - PDF)
First published: Last updated:
Overview of comments received on 'guideline on similar biological medicinal products containing monoclonal antibodies' (EMA/CHMP/BMWP/403543/2010)
Reference Number: EMA/205886/2012
English (EN) (1.52 MB - PDF)
First published: Last updated:
Draft guideline on similar biological medicinal products containing monoclonal antibodies
Consultation dates:
to Draft: consultation closedReference Number: EMA/CHMP/BMWP/403543/2010
English (EN) (194.94 KB - PDF)
First published: Last updated:
Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies
Consultation dates:
to Draft: consultation closedReference Number: EMEA/632613/2009
English (EN) (56.83 KB - PDF)
First published: Last updated:
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