FDA updates Purple Book database

Biosimilares/General | Posted 25/09/2020 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has updated its searchable Purple Book database to include allergenic, cellular and gene therapy, haematologic and vaccine products.

Purple Book V14I12

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

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 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved

Source: Mintz, US FDA

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010