AAM, Biosimilars Council applaud FDA’s release of enhanced Purple Book

Sandra Levy
Senior Editor
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The Food and Drug Administration on Monday debuted the first version of its searchable online database of biological product information, known as the Purple Book.

The database, which builds on previous PDF lists of biological products, will enable easier searches and includes information on product names, both proprietary and proper, the type of biologics license application, or BLA, that was submitted; strength of the biologic; dosage form; product presentation; license status; BLA number; and approval date.

The Association for Accessible Medicines and the Biosimilars Council applauded the FDA’s action, stating that it will continue to call on policymakers to support legislation that would require all patents for the reference biologic to be listed in the Purple Book.

"Today’s FDA action to enhance the Purple Book is a boon to those seeking to bring biosimilars to America’s patients," said Christine Simmon, executive director, of the Biosimilars Council. “This update creates a single searchable electronic database that identifies each biosimilar and interchangeable biologic with its reference product, increasing transparency for patients, providers, payers, manufacturers and other stakeholders.” 

Simmon added that by increasing the utility of the Purple Book, the agency is helping to close both educational and regulatory gaps that will foster patient access to FDA-approved biosimilars and increase their utilization to lower prescription drug costs. For example, the Biologic Patent Transparency Act (S. 659), a bipartisan bill sponsored by Sens. Susan Collins and Tim Kaine, would increase market-based competition for biologics by helping biosimilar makers cut through patent thickets that delay biosimilars from coming to the market. 

“We look forward to providing formal public comments to the docket to inform the next phases of development," she said.