FDA Purple Book - McDermott+Consulting

FDA Purple Book

The Food and Drug Administration released the “Purple Book Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity of Interchangeability Evaluations”.  To view the lists on the FDA’s website, please click here.

According to the FDA, these lists will help users to see whether a particular biological product has been determined by the FDA to be a reference biologic, a biosimilar, or to be interchangeable with a reference biological product.

For more information about these lists, see the FDA’s fact sheet.