On September 9, 2014, FDA released the first edition of the "Purple Book," which is the analogue to the Orange Book for biologics. The Orange Book has long been used by regulators and doctors to look up approved drugs and their therapeutic equivalents. The new Purple Book will perform a similar function for biological products licensed by FDA under the Public Health Service Act, although unlike the Orange Book it does not include a listing of patents. The Purple Book lists the date a biological product was licensed and whether FDA determined the biologic to be biosimilar to or interchangeable with a reference biological product. Biosimilar and interchangeable biological products will be listed under the reference product to which biosimilarity or interchangeability was demonstrated. The Purple Book will also note whether FDA evaluated the biological product for reference product exclusivity and the expiration date of any exclusivity. FDA provides additional background information on its website.
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