Lessons Learned from Biosimilar Drug Development

Posted 19 December 2016 By Raymond A. Huml, MS, DVM, RAC , Nigel Rulewski, MD

placeholder+image This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development.

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Categories: Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy, Features, US, Europe, FDA, EMA

Tags: Biosimilars

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