Summary Of The Purple Book

Keyword:, Purple book

The US Food and Drug Administration (FDA) published the first edition of the Purple Book on September 9, 2014. It is formally known as the Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. It was published several years after the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010.
The primary purpose of the book is to provide information about whether or not licensed biological products are categorized as biosimilar or interchangeable with a reference biological product by the FDA. It also contains details about existing reference product exclusivity, which protects a reference biological project.
Although FDA was not required under BPCIA to publish a list of licensed biological products, the same way the Hatch-Waxman Amendments did, the agency took the initiative to provide a reference guide to anyone who will find it useful.

According to the FDA, it is a nickname that is easy to remember. It also draws upon the agency’s long-held practice of using colors as nickname. The Approved Drug Products with Therapeutic Equivalence Evaluations, for example, is nicknamed as the Orange Book.
What are the two sections of the book?
The Lists of Licensed Biological Products is a compilation of lists organized by the FDA Center: Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
So each section is labeled as:
(1) Center for Biologics Evaluation and Research (“CBER”) List of Licensed Biological Products
(2) Center for Drug Evaluation and Research (“CDER”) List of Licensed Biological Products
What exactly is its content?
• Each listing include the following information:
• Biologic license application (BLA) number
• Nonproprietary product name
• Brand