Pfizer Announces FDA Approval of Nivestym™ (filgrastim-aafi)

On July 20, 2018, Pfizer issued a press release reporting that the U.S. FDA has approved Nivestym™ (filgrastim-aafi), Pfizer’s proposed biosimilar of Neupogen®, for all eligible indications of the reference product.  Pfizer states that “NIVESTYM is expected to be available in the U.S. at a significant discount to the current wholesale acquisition cost (WAC) of Neupogen. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.”

Nivestym™ is the twelfth biosimilar, and Pfizer’s fourth, to obtain FDA approval through the BPCIA pathway, and the first biosimilar of Neupogen® to get approved by FDA since Sandoz’s Zarxio® in March 2015.

Nivestym™ is the subject of a BPCIA patent litigation that Amgen filed just two days ago against Pfizer and its subsidiary Hospira.