Biologics Price Competition and Innovation Act – Page 2

Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

Sep 15 2014

On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”). 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. Read More

FDA Accepts First Biosimilar Application Filed Under Section 351(K) of the Public Health Services Act

Aug 06 2014

On 24 July 2014, over four years after the enactment of the Biologics Price Competition and Innovation Act, the FDA accepted its first biosimilar application from Sandoz Inc. (Sandoz). Sandoz’s application is for a biosimilar version of Amgen Inc.’s (Amgen) Neupogen® (filgrastim). Neupogen® is a pharmaceutical analog of human granulocyte colony stimulating factor that is used to treat neutropenia, a condition where the body does not make enough neutrophils, a type of white blood cell. Amgen’s Neuprogen® is indicated for use by patients receiving strong chemotherapy to reduce their risk of infection. Read More

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