The Purple Book: Transition to a single online source

By Dr Nicola Davies

In February 2020, the US Food and Drug Administration announced its plans to enhance the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” a database of all FDA-licensed biological products. The database is colloquially referred to as the “Purple Book.” The agency seeks to improve the accessibility of information related to biological products, including interchangeable products and biosimilars, through expansion and digitization of the Purple Book, notes Dr Nicola Davies in her exclusive article for The Pharma Letter. According to the FDA Commissioner, Dr Stephen Hahn, the planned enhancement to the database should “increase transparency for patients, industry users and other stakeholders.” 1

This article discusses the current status of the Purple Book and explores the enhancements that are expected in future releases of the online database.