Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

The Purple Book - medThe “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).

The Purple Book includes the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.

The Purple Book, in addition to the date licensed, also includes whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the PHS Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the Affordable Care Act known as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Healthcare providers can prescribe biosimilar and interchangeable biological products just as they would prescribe other medications. The BPCI Act describes an interchangeable product as a product that may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. In contrast, FDA expects that a biosimilar product will be specifically prescribed by the healthcare provider and cannot be substituted for a reference product at the pharmacy level.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically.

Page Last Updated: 10/20/2016
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