The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by Federal Drug Administration (FDA) under the Public Health Service Act (PHS Act). The lists include 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" will also enable a user to see 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).
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.
The products liste below were copied directly from the FDA's website on July 20, 2015:
- CBER List of Licensed Biological Products (PDF), updated June 22, 2015
- CDER List of Licensed Biological Products (PDF), updated June 30, 2015