Blog Big Molecule Watch February 24, 2020

FDA Launches First Phase of Searchable Purple Book Website

Today the FDA launched a partial searchable version of the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations”, colloquially known as the “Purple Book“.

According to the FDA’s press release, the Purple Book is now available both as lists and a searchable, online database.  The lists contain information about all FDA-licensed biological products, while the searchable database contains information about a limited number of FDA-licensed biological products, specifically, licensed biosimilar and interchangeable products and their reference products.  Today’s launch represents the first step in fully digitizing the Purple Book, and FDA is currently working to expand the online database.  In particular, subsequent releases will expand the number of FDA-licensed biological products in the searchable database until it includes information about all FDA-licensed biological products.  The FDA’s Background Information page on the Purple Book also explained that transition biological products (approved NDA’s that will be deemed BLA’s) will be included in the Purple Book shortly after the transition date of March 23, 2020.

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