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

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

Adopted Reference Number: EMA/CHMP/BMWP/403543/2010 Legal effective date: 01/12/2012

Document history

Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues

Adopted Reference Number: EMA/CHMP/BMWP/403543/2010 Legal effective date: 01/12/2012

Overview of comments received on 'guideline on similar biological medicinal products containing monoclonal antibodies' (EMA/CHMP/BMWP/403543/2010)

Reference Number: EMA/205886/2012

Draft guideline on similar biological medicinal products containing monoclonal antibodies

Draft: consultation closed Consultation dates: 18/11/2010 to 31/05/2011 Reference Number: EMA/CHMP/BMWP/403543/2010

Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies

Draft: consultation closed Consultation dates: 01/10/2009 to 31/01/2010 Reference Number: EMEA/632613/2009