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Bradford R. Hirsch and Gary H. Lyman

formulations of these previously introduced therapeutic proteins. These agents, referred to by several names, including biosimilars, biogenerics, follow-on biologics , and subsequent-entry biologics , will enter the United States market with patent

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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

Act of 2009, Pub. L. No. 111–148 , Title VII, Subtitle A “Biologics Price Competition and Innovation Act of 2009,” § 7001 – 7003 . 2. Jelkmann W . Biosimilar epoetins and other “follow-onbiologics: update on the European experiences

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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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Michaela A. Dinan, Bradford R. Hirsch and Gary H. Lyman

with the introduction of biosimilars, also known as follow-on biologics . The introduction of tbo-filgrastim and forthcoming CSFs could drive down the price of the reference agents. 33 However, whether biosimilars will be readily adopted into US

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Jennifer M. Hinkel, Edward C. Li and Stephen L. Sherman

chronic renal failure indication and the treatment of chemotherapy-induced anemia. To date, these 2 ESAs are the only agents available in the United States market, although various “biosimilar” (often referred to in the United States as “follow-on biologic