The “Purple Book” originally was available as two separate lists of FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER) and FDA-licensed biological products regulated by the Center for Biologics Evaluation and Research (CBER).
The FDA has transitioned the Purple Book to a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act.
Currently, the searchable database contains information about all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products, and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER.
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