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Operational Challenges Associated with Biosimilar Drug Development

This article examines the current operational landscape of biosimilar clinical drug development and identifies opportunities to decrease the risks associated with increasing competition. With an emphasis on European Union and United States’ markets, it gives an overview of some of the challenges and issues that need to be considered by researchers in this increasingly crowded environment, explains Niti Goel, Rod Hepburn, Scott Davis, Deepa Dahal, Tracy Stewart, and Kamali Chance from Quintiles.