FDA Launches Searchable Purple Book

Regulatory NewsRegulatory News | 24 February 2020 |  By 

The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book.

Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date.

Biopharma companies previously requested that FDA include exclusivity information in the Purple Book, similar to what’s offered in the Orange Book, and FDA says that a later iteration of the database will include such dates.

“Once the Purple Book database is completed, it will offer information about all licensed biological products, including information pertaining to exclusivity,” FDA said.

Christine Simmon, executive director of the Biosimilars Council, applauded FDA’s work on the Purple Book and called on policymakers to support legislation that would require all patents for the reference biologic to be listed in it.

FDA said the database will be updated with new drug applications that are deemed to be BLAs on 23 March and will “continue to be updated through August 2020 when all functionality and all BLAs are expected to be available on the new Purple Book online database.”

The Purple Book, which currently contains 89 entries, will be updated on a weekly basis and newly approved biosimilars or interchangeable products, and their respective reference products, will be included in the database within 10 business days, FDA said.

Information on when biosimilars launch, however, will not be included in the Purple Book.

Purple Book


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