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  6. Therapeutic Biologics Applications (BLA)
  7. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
  1. Therapeutic Biologics Applications (BLA)

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

The Purple Book - medThe “Purple Book” originally was available as two separate lists of FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER) and FDA-licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER). The FDA is working to transition to a searchable, online database that contains information about all biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act. Currently, the list contains information about FDA-licensed biological products regulated by CBER. The new, searchable database contains information about all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products.

FDA is working to expand the Purple Book by transitioning from a list format into a searchable database that is accessible online. This enhanced Purple Book is being released in multiple phases. The initial release included all FDA-licensed biological products regulated by CDER. Subsequent releases will include all FDA-licensed biological products regulated by CBER, in addition to enhanced functionality.

The CDER List of Licensed Biological Products will no longer be available now that all FDA-licensed biological products regulated by CDER can be found in the Purple Book: Database of Licensed Biological Products. The CBER List of Licensed Biological Products will continue to be updated until those products are in the Purple Book Database.

The list of licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER) will be updated periodically.

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