FDA Purple Book: quick access (IBD biologics)

Educational reference only

This page opens the official U.S. FDA Purple Book in a new tab. It does not provide medical advice and does not recommend switching products. The FDA Purple Book is the authoritative source for licensed biological products, including biosimilar and interchangeable listings. Clinical decisions belong with the treating clinician and pharmacist.

The FDA hosts two main ways to search. Simple Search on the homepage is often the fastest way to see products that share a core name (reference, biosimilar, and interchangeable), per the Purple Book FAQs. Advanced Search shows the full data table with filters.

Purple Book homepage (simple search)Advanced SearchDataset downloads

IBD biologics: Purple Book link per agent

Use the suggested search terms on the FDA site (brand and/or nonproprietary name). The FDA site does not support guaranteed pre-filled URLs for a given product.

Brand nameNonproprietary nameSuggested search on FDA siteFDA Purple Book
Remicadeinfliximabinfliximab or RemicadeOpen FDA Purple Book
Humiraadalimumabadalimumab or HumiraOpen FDA Purple Book
Cimziacertolizumab pegolcertolizumab pegol or CimziaOpen FDA Purple Book
Simponigolimumabgolimumab or SimponiOpen FDA Purple Book
Entyviovedolizumabvedolizumab or EntyvioOpen FDA Purple Book
Stelaraustekinumabustekinumab or StelaraOpen FDA Purple Book
Skyrizirisankizumab-rzaarisankizumab-rzaa or SkyriziOpen FDA Purple Book
Omvohmirikizumab-mrkzmirikizumab-mrkz or OmvohOpen FDA Purple Book
Tremfyaguselkumabguselkumab or TremfyaOpen FDA Purple Book

Regulatory notice

This website is independently developed and is not affiliated with, endorsed by, or sponsored by the FDA. For the current product list, always rely on purplebooksearch.fda.gov.