Biosmiliars Get Their Own FDA 'Purple Book'

Friday, October 3, 2014

Source: FDA News

The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable.

The book is similar to the Orange Book for small molecules and represents another step forward as the agency prepares its biosimilar approval pathway.

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