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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Second Biosimilar Application Filed Under BPCI Act by Celltrion

By: David Fazzolare and Joanna Brougher On August 8, 2011, Celltrion announced that it filed a biosimilar application under the Biologics Price Competition and Innovation Act (BPCI Act) for its infliximab biosimilar.  Celltrion's infliximab biosimlar is already marked in over 50 countries worldwide, including Europe, Canada and Japan, under the brand name of Remsima®.  Celltrion's announcement comes …

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Obtaining Early Biosimilar Patent Certainty in the Aftermath of Sandoz v. Amgen

By: David Fazzolare In December 2013, the court case of Sandoz v. Amgen became the first instance in which a court has been asked to interpret the patent litigation provisions of the Biologics Price Competition and Innovation Act (the “Biosimilars Act”), the outcome of which may have significant impact on future biosimilar development. To learn …

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