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Developing the Nation's Biosimilars Program

List of authors.
  • Steven Kozlowski, M.D.,
  • Janet Woodcock, M.D.,
  • Karen Midthun, M.D.,
  • and Rachel Behrman Sherman, M.D., M.P.H.

To improve access to biologic drugs, Congress authorized the FDA to create an abbreviated pathway for approving biologics that are “biosimilar” to approved products. Reconciling the science of biosimilar development with a new regulatory framework is challenging.

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Funding and Disclosures

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Author Affiliations

From the U.S. Food and Drug Administration Center for Drug Evaluation and Research (S.K., J.W., R.B.S) and Center for Biologics Evaluation and Research (K.M.), Silver Spring, MD.

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