How pharmacists can keep up with biosimilar approvals

The Food and Drug Administration (FDA) has released its lists of approved biosimilar licensed products, called the “Purple Book”. The invaluable site includes the date a biological product was licensed under the PHS Act and whether FDA evaluated the biological product for reference product exclusivity.

The Purple Book also enables users to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with an already-licensed FDA biological product.

“Professional care and judgment should be exercised in using these lists,” the FDA wrote in its document explaining the Purple Book. “FDA’s determination that a product is biosimilar to a reference product or interchangeable with a reference product means that FDA has determined that the biological product meets the requirements for such products.”

While the FDA has not made a determination of the date of first licensure for all 351(a) biological products included on the lists, it does not mean that the biological products on the list are not, or were not, eligible for exclusivity.

“A determination of the date of first licensure and of when any remaining reference product exclusivity will expire for a biological product submitted under section 351(a) of the PHS Act will generally be made for reasons of regulatory necessity and/or at the request of the 351(a) application license holder,” the FDA wrote.

As resources permit, the biosimilar lists will be updated periodically when FDA licenses a biological product under section 351(a) or section 351(k) of the PHS Act and/or makes a determination regarding date of first licensure for a biological product licensed under section 351(a) of the PHS Act.

For questions on the lists or to suggest changes, contact FDA’s Division of Drug Information (CDER) at 855 543-3784 or email druginfo@fda.hhs.gov.