Purple Book: Licensed Biological Products

Purple Book: Licensed Biological Products

Today, the Food and Drug Administration (FDA) is releasing the first phase of the enhancement of the “Purple Book: Database of FDA-Licensed Biological Products” (Purple Book), transitioning the current table format “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” to a searchable, public-facing online database.  The first phase of the new Purple Book database will provide the public with information about FDA-licensed biological products, including biosimilar and interchangeable products, through a dynamic, accessible, easy-to-use online search engine.

The initial Purple Book Version contains a limited data set that includes all approved biosimilar products and their related reference products, with simple search and advanced search functionality.  FDA will also publish a Federal Register notice and open a docket to gather public comment on the database to inform the next phases of development.  FDA intends to release additional phased enhancements to the database that take user testing and stakeholder input into consideration as additional functionality and improvements are developed and implemented. The enhanced Purple Book is expected ultimately to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products, in addition to enhanced functionality. 

While FDA is working to expand the Purple Book by transitioning from the current list format to a searchable online database, the static PDF will continue to house information on all FDA-licensed biological products.

Once the Purple Book Database is completed, it will offer information about all licensed biological products, and the list/PDF format of the purple book will not continue to be updated.

The new Purple Book database is intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including biosimilar and interchangeable products, and to advance public awareness about licensed biological products.