The FDA’s Purple Book is a list of all its licensed biological products, including reference products and biosimilar and interchangeable products. It dates back to 1985 and enables users to check if an approved product has a biosimilar version or when a patent is due to expire on a reference product, for example.

It was previously available as two lists, separated by products regulated by the Center for Drug Evaluation and Research (CDER) and by the Center for Biologics Evaluation and Research (CBER).

In February 2020 [1], FDA announced plans to transition the Purple Book to a searchable, online database. The transition is intended to improve transparency and user-friendly searching capability, however, the initial update available in February provided limited searchable data. The agency followed this up in March by opening a docket for public feedback on the database. 

In August 2020, the agency further expanded the database to include all biological products regulated by CDER and additional information on allergenic, cellular and gene therapy, haematologic, and vaccine products regulated by CBER. The agency also updated its exclusivity information.

The exclusivity information will now identify whether a biological product has been evaluated for reference product, orphan, paediatric, or first interchangeable exclusivity, along with corresponding exclusivity expiration dates (if available). Previously, it only included known exclusivity expiration dates.

The transition to a fully searchable online database is ongoing and will ultimately provide information about all FDA-licensed biological products without the need for a PDF list that requires updating.

FDA has also recently announced changes to the regulation of its master files for biological drugs, which were previously administered by CDER but as of March 2020 are regulated by CBER [2].

Related articles
FDA releases new information on interchangeable biologicals

FDA’s Orange and Purple Books to be improved and updated

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA publishes historic drug approvals and searchable Purple Book [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/General/FDA-publishes-historic-drug-approvals-and-searchable-Purple-Book
2. GaBI Online - Generics and Biosimilars Initiative. Center for Biologics Evaluation and Research to regulate biological master files [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Guidelines/Center-for-Biologics-Evaluation-and-Research-to-regulate-biological-master-files 

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