NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives

Authors:
Andrew D. Zelenetz
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 MD, PhD
,
Islah Ahmed
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 MD
,
Edward Louis Braud
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 MD
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James D. Cross
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 MD
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Nancy Davenport-Ennis
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,
Barry D. Dickinson
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 PhD
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Steven E. Goldberg
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 MD, MBA
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Scott Gottlieb
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 MD
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Philip E. Johnson
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 MS, RPh
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Gary H. Lyman
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 MD, MPH, FRCP(Edin)
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Richard Markus
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 MD, PhD
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Ursula A. Matulonis
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 MD
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Denise Reinke
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 MS, NP
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Edward C. Li
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 PharmD, BCOP
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Jessica DeMartino
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 PhD
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Jonathan K. Larsen
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 MPP
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James M. Hoffman
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 PharmD, MS, BCPS
Volume/Issue:
Volume 9: Issue Suppl_4
Online Publication Date:
Sep 2011
DOI:
https://doi.org/10.6004/jnccn.2011.0136
Restricted access

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.

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Print ISSN:
1540-1405
Online ISSN:
1540-1413
Publisher:
National Comprehensive Cancer Network
Cover Journal of the National Comprehensive Cancer Network
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Copyright:
Copyright © 2011 by the National Comprehensive Cancer Network
Article Category:
Research Article
Print Publication Date:
01 Sep 2011
Online Publication Date:
Sep 2011
Keywords:
Biosimilars; follow-on biologics; health policy

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