FDA Unveils Searchable Purple Book Database

The FDA released a new version of its Purple Book for biological product developers in a searchable database that links each biosimilar and interchangeable with its reference product.

The searchable database initially includes a limited data set for all approved biosimilar products and their respective reference products that can be perused using basic or advanced filters, but the agency said it plans to release additional enhancements that take industry feedback into account.

FDA Commissioner Stephen Hahn said the searchable database will “facilitate the acceptance and use of existing biosimilar products and the development of new ones.”