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  1. FDA In Brief

FDA In Brief: FDA Enhances Purple Book to Support Transparency in Biosimilars

February 24, 2020

Media Inquiries

  Jim McKinney
  240-328-7305

The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.:

“This expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.

“We’re confident these enhancements will meet the needs of a wide range of users, from providing a simple search for patients and consumers, to a more advanced search for prescribers, researchers and industry representatives that may have a need for more technical information.

“Providing stakeholders with more information about biological products through a modernized platform should better facilitate the acceptance and use of existing biosimilar products and the development of new ones, potentially leading to lower costs for patients and improved access to safe, effective, high-quality medications.”

  • The U.S. Food and Drug Administration is upgrading the Purple Book, otherwise known as the “Database of FDA-Licensed Biological Products,” in phases, starting today, with full search functionality for all approved biosimilar products and their reference products. Subsequent phases are expected to expand the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.
  • The new 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 enhancements to the Purple Book also include more information about approved biological products (such as including information pertaining to exclusivity, and whether a product has demonstrated that it is biosimilar to, or interchangeable with, a reference product), intended to help patients and industry track the licensure statuses of biosimilar and interchangeable biological products, and to aid prescribers and pharmacies in identifying life-saving, and potentially cost-effective medications.
  • The FDA will also 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.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.