About Purple Book

The Purple Book is a database that contains information about all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products. The Purple Book also contains information on all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).

Some of the information you can find in the Purple Book includes:

• The date on which a biological product was licensed under section 351(a) or 351(k) of the Public Health Service Act (PHS Act).
• Whether a biological product licensed under section 351(k) of the PHS Act has been determined by the FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product).
• The date of expiration of applicable exclusivity for a biological product if FDA has determined that the biological product is eligible for reference product exclusivity under section 351(k)(7) of the PHS Act or first interchangeable biological product exclusivity under section 351(k)(6) of the PHS Act, as appropriate.
• Patent information for certain licensed biological products required by the Biological Product Patent Transparency section of the Consolidated Appropriations Act of 2021. See FAQs 5-7 for more information.

The Purple Book database contains information for multiple users (e.g., patients, the general public, healthcare providers, manufacturers, and researchers). For all users, please visit the User Guide for specific instructions on how to use the Simple Search and Advanced Search, as well as how to access a product’s labeling.

• Patients and the General Public may find the Purple Book ‘Simple Search’ useful to find information about a biological product they are currently taking or may be prescribed and to view options for FDA-approved biosimilar and interchangeable products.
   
• Healthcare Providers may find the Purple Book ‘Simple Search’ useful to see all associated products for a biological product they prescribe or are considering prescribing for a patient, including biosimilars and interchangeable products. Healthcare providers may also find the ‘Advanced Search’ useful to search using additional terms, including strength, dosage forms, or product presentations (e.g., Autoinjector).
  
  The ‘Product Label’ (e.g., Prescribing Information) icon/link associated with each product in the database directs users to information a healthcare provider may find useful when prescribing a product. See the User Guide for more information on accessing product labeling.
   
• Manufacturers and Researchers may find the ‘Advanced Search’ useful as it allows users to view and sort all available information in a table format, as well as download the results and information as an Excel, CSV or PDF file.