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FDA Greenlights Updates to the Purple Book Database

As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and more user-friendly search functionality for the biological product and biosimilar industries.  In a prior post, we noted that an enhanced Purple Book was a “priority deliverable” for the agency under the Biosimilar Action Plan. The transition of the Purple Book to a searchable online database is one such enhancement. The August 3, 2020 release offers additional information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER), expanding the dataset used by the database. FDA also updated the available exclusivity information for further industry ease of reference. This update is the next phase of the agency’s plan to improve the accessibility of information related to biological products through expansion and digitization.

The Purple Book Database’s primary purpose is to enable users to see if an FDA-licensed biological product is biosimilar to or interchangeable with a reference biological product (an already-licensed innovator biological product). In addition, it provides information on product exclusivity protecting a reference biological product. Until recently, the Purple Book consisted of two separate lists of current FDA-licensed biological products: those regulated by the Center for Drug Evaluation and Research (CDER) and those regulated by CBER. Now, FDA is transitioning the Purple Book to a single, searchable online database of licensed biologics. The transition will occur in phases. According to FDA, the online database is “intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including whether there are biosimilar and/or interchangeable product options, and to advance public awareness about FDA-licensed biological products.”

FDA’s last Purple Book Database update, in February 2020, contained limited searchable data on all approved biosimilar products and their related reference products. In March 2020, FDA opened a docket for public comments to gather feedback to enhance the database and to inform the next phase of development.

This most recent release adds information for all FDA-licensed biological products regulated by CDER and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER. Also, an updated glossary, downloadable monthly report, and additional database functionality will ease usability.

Aside from the new informational releases to the database, FDA included additional exclusivity information. This information relates to orphan, pediatric, and first interchangeable exclusivity.  The database previously only included known exclusivity expiration dates. Now, the exclusivity information in the Purple Book will identify whether a biological product has been evaluated for reference product, orphan, pediatric, or first interchangeable exclusivity, along with corresponding exclusivity expiration dates, if a date has been determined.

Following the database updates, FDA will cease updating the current list of biological products maintained by CBER.

According to FDA, updating of the Purple Book Database is an ongoing process. FDA hopes to transition the current list format into a fully functional searchable online database. Once completed, it will offer information about all licensed biological products without the need for a PDF list that routinely requires updating. Industry can expect additional database updates in the future.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume X, Number 219

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About this Author

Elizabeth K. Conti Associate Mintz DC FDA Regulatory Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Consumer Product Safety
Associate

Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceuticals, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors.

She advises clients on FDA regulations related to labeling, advertising, importing and exporting, and manufacturing practices. Her practice also encompasses administrative matters and civil litigation related to DEA requirements. On the enforcement defense side of her practice, Elizabeth counsels clients on fraud and abuse compliance and litigation...

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