Purple Book: Licensed Biological Products

Purple Book: Licensed Biological Products

Today, the Food and Drug Administration (FDA) is releasing an update to the Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated by the Center for Drug Evaluation and Research (CDER) including biological products approved in new drug applications (NDAs) that were deemed to be licenses under section 351 of the Public Health Service Act on March 23, 2020 (transition biological products). This release also includes additional downloadable report features. Historical reports will now include a section highlighting changes made during the previous month – for example, the monthly data download will include a section at the top highlighting all new/updated products during the selected month. 

This is the second phase of the “Purple Book: Database of FDA-Licensed Biological Products” (Purple Book) enhancement, 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. 

Subsequent releases will include information about all FDA-licensed biological products regulated by Center for Biologics Evaluation and Research (CBER), in addition to enhanced functionality. 

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

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.