Big Molecule Watch
July 20, 2018

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.

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