FDA enhances Purple Book with biosimilars upgrade

By The Science Advisory Board staff writers

February 24, 2020 -- The U.S. Food and Drug Administration (FDA) will be upgrading the Purple Book, a database of FDA-licensed biological products, beginning on February 24. Early-phase upgrades will include full search functionality for all biosimilar products and their reference products.

Subsequent upgrades are expected to expand the dataset in the Purple Book to include data and information about products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), including transition biological products.

The database includes information about FDA-licensed biological products, such as the product's proprietary and proper names, the full product label, dosage form, route of administration, strength, marketing status, and more.

The upgrades are intended to help patients and industry track the licensure statuses of biosimilars by including information regarding exclusivity and whether a product has demonstrated it is biosimilar to or interchangeable with a reference product.

The FDA plans to open a public docket to gather stakeholder feedback on the new database with enhanced functionality that the agency will review to inform the next phases of development.

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