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.
The publication of the Purple Book comes several years after the enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010, which established an expedited pathway for FDA approval of biosimilars. Since the enactment of the BPCIA, many organizations have supported the creation of an Orange Book equivalent for biological products. The Purple Book takes a significant step toward this goal, and will list those biological products that have been “licensed” or approved by FDA under section 351(k) of the Public Health Service Act (“PHSA”). Notably, FDA’s release of the Purple Book comes a little over a month after the filing of the first biosimilar application under section 351(k) and points to FDA providing further clarity regarding biosimilars in the coming months, such as the naming of biosimilars.
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