Posted 01 March 2016
By Raymond Huml, MS, DVM, RAC, Nigel Rulewski, MD, Kamali Chance, MPH, PhD, RAC, Doris Weilert, PhD, J. Rick Turner, PhD
This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development.
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Categories: Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy, Features, US, Europe, FDA, EMA, EC
Tags: Biosimilars, Clinical development, CMC