The Purple Book is modeled after the Orange Book, a list of every prescription drug approved by the FDA for safety and effectiveness that was first published in 1980.
The Purple Book contains information on biological product names, type of biologics license application submitted to the FDA, the strength of the biologic, the dosage form, product presentation, license status, BLA number and approval date.
A later version of the database will include exclusivity info as well, the FDA said.
The book will be updated weekly, and newly approved biosimilars or interchangeable products and their respective reference products will be included in the database within 10 business days, according to Regulatory Focus.
Information on when biosimilars launch will not be included in the Purple Book.
Read the full news release here.
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