FDA Publishes “Purple Book” to Catalog Biologics, Interchangeable and Biosimilar Products
The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” otherwise known as the “Purple Book.” The announcement of the Purple Book comes weeks after the FDA received its first two applications for biosimilars under section 351(k) of the Public Health Services Act (“PHS”).
The Purple Book will list all biological products licensed by the FDA under section 351(a) of the PHS Act, as well as biosimilar and interchangeable products licensed under section 351(k) of the PHS Act. The Purple Book will include, for products licensed under 351(a), the date the product was licensed and whether it was evaluated by the FDA for reference product exclusivity under the PHS Act. If the 351(a) product is subject to a reference product exclusivity period, the Purple Book will also include the date that period expires. Each biosimilar or interchangeable product will be listed with the reference biological product to which it is biosimilar or interchangeable.
The Purple Book will serve as the biopharmaceutical equivalent of the “Orange Book,” which since 1980 has published all pharmaceutical drug products the FDA has approved or have not been withdrawn due to issues of safety or efficacy. It is expected that the Purple Book will function in the same way as the Orange Book, but will not be as extensive at this initial stage.
The Purple Book will be a helpful resource in identifying information on the status of biosimilar and interchangeable applications in the U.S. For more information on IP strategies for biosimilars, please contact a member of our team.
