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Andrew D. Zelenetz, Islah Ahmed, Edward Louis Braud, James D. Cross, Nancy Davenport-Ennis, Barry D. Dickinson, Steven E. Goldberg, Scott Gottlieb, Philip E. Johnson, Gary H. Lyman, Richard Markus, Ursula A. Matulonis, Denise Reinke, Edward C. Li, Jessica DeMartino, Jonathan K. Larsen and James M. Hoffman

. Patents for older biologics will soon expire, and the United States is developing a regulatory process for the approval of similar biologics (biosimilars). Therefore, the safe and appropriate incorporation of biosimilars into clinical practice for patients

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Bradford R. Hirsch and Gary H. Lyman

approval of biosimilars in Europe Evaluate the potential economic impact of biosimilars Distinguish the most promising system for monitoring the quality of biosimilars Background on Biosimilars As the name implies, biologics encompass a range of medicinal

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Andrew D. Zelenetz and Pamela S. Becker

The Debut of Biosimilar Agents: Myeloid Growth Factors Are the First Act As cancer biologics move off-patent, biosimilars are coming on board. In March 2015, the first biosimilar agent was approved for an oncology indication: the recombinant

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Gary H. Lyman

twice that of the median household budget in the United States. Although drugs are not the only driver of healthcare costs, the introduction of biosimilars for drugs known and trusted for many years is one possible solution,” explained Gary H. Lyman, MD

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Bradford R. Hirsch and Gary H. Lyman

Background Biosimilars, also known as follow-on biologics, continue to be an area of great interest in oncology because of the potential cost savings and improved access related to their use, yet significant confusion remains regarding their

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Katy Winckworth-Prejsnar, Elizabeth A. Nardi, Lisa Korin Lentz, Jeffrey A. Crawford, C. Lyn Fitzgerald and Robert W. Carlson

Executive Summary Molecular testing and biosimilars offer the potential for increased access to targeted treatment options and reduction in healthcare costs, but come with significant challenges to therapeutic decision-making, safety, efficacy

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Jessica K. DeMartino

, complicated and patented manufacturing processes, immunogenicity issues, and analytical issues related to determining properties unique to these agents. Second, the clinical consequences of subtle differences in biosimilar products may vary; therefore

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Chadi Nabhan and Bruce A. Feinberg

additional pressure for drug-savings measures. 1 Some experts have proposed that biosimilars could mitigate this continued upslope through competing market prices relative to their reference product. This is especially relevant because many patents for

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Margaret Tempero

write these editorials, so I keep a list of things that I should learn more about. One of the things on my list was biosimilar agents. I knew there was controversy about these drugs, but that was about where my investigation had stopped. What are these

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Jessica DeMartino

In April 2013, NCCN held the NCCN Oncology Policy Summit, “Evolving Policy Issues in Oncology—Revisiting Biosimilars and Molecular Testing” in Washington, DC. Stakeholders gathered to examine how biosimilars and molecular testing in oncology