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Expert Analysis

Purple Is The New Orange: A New Book On Biosimilars

Law360, New York (September 22, 2014, 10:37 AM EDT) -- On Sept. 9, 2014, the U.S. Food and Drug Administration published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. The Purple Book is the biological equivalent of the pharmaceutical Orange Book and seeks to aid regulatory agents, generic manufacturers and physicians by arming them with information related to biological products, such as biosimilars including, for example, providing information regarding the interchangeability of products....

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