The FDA Purple Book Database: A Valuable Research Tool
So, what exactly is the FDA Purple Book Database?
First a few things it is not:
- a book
The Purple Book Database is a list (downloadable or searchable on-line at https://purplebooksearch.fda.gov/ ) of all FDA approved biological products regulated by either CDER or CBER, including:
- licensed biosimilars and interchangeable products and their reference products
- All biological products approved in NDAs that were deemed to be BLAs on March 23, 2020 (transition biological products)
- allergenic, cellular and gene therapy, hematologic, and vaccine products
Originally established as two separate lists (one from CDER and one from CBER), the two lists were combined in February 2020 and only the combined list is now being updated with new approvals.
The original focus of the list was on biosimilars and reference product exclusivity periods, i.e., the 12 years after first licensure of a biological product during which a 351(k) application (a biosimilar application) cannot be approved. However, the list contains much valuable information that can be used in biologic product development. A few examples include:
- The proprietary name, proper (generic) name and BLA number of every licensed biologic. These data can be used to search the FDA website for approval information for that biologic, which can include the approval memos prepared by FDA reviewers, copies of information requests from FDA to the sponsor during the review process, and post-approval commitments and requirements. The savvy biologic developer can use information gleaned from similar products to avoid development pitfalls and shorten timelines.
- All the licensed strengths of each biologic. By comparing potential competitors used in the same indication, the biologic developer can determine appropriate variations to cover the patient population or perhaps find an underserved niche area.
- The route of administration and presentation of each biologic. If the biologic developer is considering a new presentation, say a multi-dose vial, this list can be used to find examples for further research into formulations or prescribing information that supports this presentation.
Food and Drug Administration (FDA). (2020). Purple Book Database of Licensed Biological Products. Retrieved from source.