Post Tags

The Purple Book: The FDA Announces Welcome Enhancements

Earlier this week, the FDA announced that it has made enhancements to the Purple Book. These changes improve how information related to biological and biosimilar products is accessed through the use of a simple internet search. For readers unfamiliar with the Purple Book, it is a database of FDA-licensed biological products. However, until these recent updates, the Purple Book only existed as two lists, one from the Center for Biologic Evaluation and Research and one from the Center of Drug Evaluation and Research. Both of these lists contained current licensed biological products with reference to product exclusivity and any biosimilarity or interchangeability evaluations that have occurred. But unlike the Orange Book for FDA-approved small molecule drugs, the Purple Book does not contain a list of patents covering the drug or its use. Instead, the Purple Book includes significant dates for information relevant to the procedures outlined in the Biologics Price Competition and Innovation Act (BPCIA) for the approval and patent-resolution processes for biosimilar versions of approved biologic drugs. These dates and information include the date the product was licensed, and whether the FDA has evaluated it for reference product exclusivity.

The fact that the Purple Book does not contain patent information is commonly misunderstood, likely caused in part by the similarity in name to the Orange Book (and the fact that the BPCIA was fashioned to be a version of the Hatch-Waxman act for biological drug products). This difference between the Purple Book and the Orange Book may be because of the different types of patents that tend to be significant for biologics, especially at the time regulatory data exclusivity expires. Accordingly, when Congress enacted the BPCIA, it left it up to the parties involved to resolve patent-list issues during the so-called “patent dance.”

The recent enhancements to the Purple Book do not address the patent-listing issue. In fact, they don’t really change what information is publicly available about licensed biological drugs. Instead, as mentioned above, the changes relate to what information is available to be accessed through the Purple Book search tool. According to the February 24, 2020 press release, the list of products available now for full search functionality is limited to all approved biosimilar products and their reference products. Additional drug products will be introduced in phases. This new database will not only include the information found in the previous spreadsheets (which will continue to be maintained for the foreseeable future, at least until the online Purple Book is completed), but also will include such information as the product’s proprietary and proper names; information relevant to prescribing the product, including dosage form, route of administration, and strength; and links to the product label. This information is touted as being able to help patients and others in the industry track the status of biosimilars and interchangeable biological products, and to aid doctors and pharmacies that may need more technical information. The FDA did suggest that they will gather feedback from stakeholders about these enhancements and use that information in the next phase of development. While the available content is not necessarily new, these enhancements will make it easier to search for relevant information, and so should be a welcome addition for anyone working in the biopharmaceutical industry.