Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial

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

placeholder+image 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

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