FDA releases 'Purple Book' to list biological products

ROCKVILLE, Md. — The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products — including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act — in much the same way that the "Orange Book" lists pharmaceuticals. 

 

The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book also will enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). 

 

Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

 

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will be updated periodically.