FDA Establishes “Purple Book” for Biosimilars

By: David Fazzolare and Joanna Brougher On September 9, 2014, the FDA announced the establishment of the “Purple Book” (formally entitled “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”), which is the equivalent for biologics of the FDA’s “Orange Book.” Whereas the Orange Book lists all small molecule reference …

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