FDA Publishes The Purple Book Listing Biologics
Tuesday, October 21, 2014
Separate from the commonly known Orange Book, identifying drug products approved on the basis of safety and effectiveness under the Federal Food, Drug and Cosmetic Act, the Food and Drug Administration (FDA) has also published the “Purple Book”.
The Purple Book lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product).
Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically.
The Purple Book will continue to gain importance as the use of biosimilar products is expected to increase significantly within a relatively short period of time.