The purple book

The US Food and Drug Administration (FDA) has launched its first searchable database of biological product information, called the Purple Book.

Currently, the Purple Book includes lists of all licensed biological products with reference product exclusivity and bio-similarity or interchangeability evaluations. The newly launched searchable online database currently only includes a limited number of FDA-licensed products, including bio-similars. However, the FDA is endeavouring to expand the searchable database by transitioning all products from the current PDF list format to this new database.

The new database allows for easier searches and includes more detailed information on proprietary names, the type of biologic license application (BLA), BLA number, strength, dosage form, product presentation, license status and approval date. The FDA have stated that the final versions of the database will also include the exclusivity dates found in the current lists, as requested by various bio-pharma companies.

“Once the Purple Book database is completed, it will offer information about all licensed biological products, including information pertaining to exclusivity.” 

The new enhanced Purple Book format will be rolled out in multiple phases. Once this database is completed and all biological products are available to search, the list format will no longer be available.

Access the database here.