In this article, we are going to see the overview of the Purple Book and its contents, and how it helps healthcare professionals, The FDA Purple Book contains the list of approved biological products, and here we are going to see the details of the Purple book, its contents and uses.

What is Purple Book?

It is a database containing information about licensed biological products – biosimilar and interchangeable products, and their reference products which are approved by the FDA. These biological products are regulated by CDER. It also contains products regulated by CBER

key contents

1. Biological products 
2. Biosimilars
3. Interchangeable Products 
4. Allergenic, cellular and gene therapy, hematologic Products
5. Vaccine products

Note: Previously there were two purple books one for licensed products for CDER & other for CBER, but now we can find all in the purple book online database.

Uses of the Purple Book

Purple book is mainly used by healthcare providers, researchers, the general public, pharmaceutical companies, and other stakeholders in the healthcare industry. Its main purpose lies in

1. Identifying Licensed Biological Products: The Purple Book is a database of all biological products that have been licensed by the FDA under the Public Health Service Act (PHS Act). This includes both innovator (reference) biologics and biosimilars.
2. Knowing Bio Similarity and Interchangeability: It provides information on whether a biological product is a biosimilar or an interchangeable biosimilar. Interchangeable biosimilars can be substituted with reference products without the intervention of the healthcare provider who prescribed the reference product.
3. Patent and Exclusivity Information: The Purple Book includes details on patents and exclusivity periods for licensed biological products.

Information Purple Book Provides 

1. BLA number
2. Non – Proprietary Product name
3. Proprietary Product name
4. Date product approved in the market
5. Whether the product is biosimilar or interchangeable
6. Reference product with an exclusivity expiry date
7. information for certain licensed biological products
8. Product withdrawal status from the market

Purple Book data base contains simple search and Advanced search, there is a detailed user guide on how to search the database 

1. Simple search – Patients, general public will find useful information using a simple search to know about the product they are using. whereas healthcare providers use simple search to know information about the products they prescribe.
2. Advanced Search – used by researchers, pharmaceutical manufacturers and also by health care providers. using this search, we can find all sort of information.