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Grabowski, H., & Lietzan, E. (2015-09-29). FDA Regulation of Biosimilars. In FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies. : Columbia University Press. Retrieved 5 Jul. 2022, from https://columbia.universitypressscholarship.com/view/10.7312/columbia/9780231171182.001.0001/upso-9780231171182-chapter-29.