The FDA’s new “Purple Book” lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes information on whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act, and whether the FDA has determined a biological product to be biosimilar to or interchangeable with a reference biological product.
This article is presented for informational purposes only and is not intended to constitute legal advice.