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