Dan Stanton, Managing editor

July 24, 2018

2 Min Read
Neupogen Biosimilar Success: Pfizer Banks on Discounts and Patient Confidence
Photo credit: kick_start on VisualHunt / CC BY-NC-SA

The US Food and Drug Administration (FDA) has approved Pfizer’s Nivestym; a second biosimilar of Amgen’s Neupogen (filgrastim).

In March 2015, the FDA approved its first biosimilar: a version of Neupogen called Zarxio, marketed by Novartis subsidiary Sandoz.

Three years later and a second filgrastim biosimilar is close to being available after the FDA approved Pfizer’s product NIvestym.

A spokesperson from the Biopharma firm told BioProcess Insider Pfizer will be able to compete against both Amgen’s reference biologic and Sandoz’s Zarxio.

“The availability of biosimilars to the market will create competition and drive value,” we were told. “We believe uptake and utilization of Nivestym in the US will be dependent upon multiple factors, including confidence on the part of healthcare providers and patients that the biosimilar will perform as well as the reference product and other filgrastim biosimilars.”

The spokesperson added Pfizer’s pricing and commercialization strategy will also play a part in gaining a share of the figrastim market, though specifics are yet to have been revealed.

“Nivestym is expected to be available in the US 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. By introducing biosimilars like NIVESTYM to the U.S. market, Pfizer hopes that patients and their healthcare providers will have improved access to a high-quality, potentially lower-cost treatment option.”

Number 12

Nivestym becomes the twelfth biosimilar to be approved by the FDA:

March 2015​: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen

April 2016​: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade

August 2016​: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel

September 2016​: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira

April 2017​: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade

August 2017: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira

September 2017: Amgen and Allergan’s Mvasi (bevacizumab-awwb), a version of Roche’s Avastin

December 2017: Mylan and Biocon’s Ogivri (trastuzumab-dkst), a version of Roche’s Herceptin

December 2017: Pfizer’s Ixifi (infliximab-qbtx), a version of J&J’s Remicade

May 2018: Pfizer’s Retacrit (epoetin alfa-epbx), a version of Amgen’s Epogen and Procrit

June 2018: Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb), a version of Amgen’s Neulasta

July 2018: Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Amgen’s Neupogen

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.


Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.


From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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