In which of the following its publications, the FDA publishes listing of its biosimilar and interchangeable biological products?
a. Orange Book
b. Red Book
c. Blue Book
d. Purple Book
Answer: Purple Book. FDA has released the "Purple Book," new documents listing biological products, including all biosimilar and interchangeable biological products licensed by FDA.
The lists include the date a biological product was licensed and whether FDA evaluated the biological product for reference product exclusivity, as defined under the Public Health Service Act.
The Purple Book will also list whether a licensed biological product has been determined to be biosimilar to or interchangeable with a reference biological product.
Separate lists for those biological products regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are updated periodically.