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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 05 July 2022

FDA Regulation of Biosimilars

FDA Regulation of Biosimilars

(p.414) Chapter Twenty-Two FDA Regulation of Biosimilars
FDA in the Twenty-First Century

Henry Grabowski

Erika Lietzan

Columbia University Press

The FDA requirements for products to be approved as a biosimilar to a reference biological drug product will have a profound impact on market entry, competition and cost savings to consumers.

Keywords:   Biosimilars, Biobetters, FDA, Interchangeability, Biologics Price Competition and Innovation Act, R&D costs

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