Nivestym (filgrastim-aafi) was approved for all eligible indications of the reference product, including to decrease the incidence of infection in patients with non-myeloid malignancies, and to reduce the time to neutrophil recovery and duration of fever in patients with acute myeloid leukaemia.
The product was first approved by the European Medicines Agency in 2010, and has since received the regulatory green light in more than 50 countries.
This latest approval marks the US Food and Drug Administration’s (FDA) second for a biosimilar version of Amgen’s Neupogen (filgrastim), following Sandoz’s Zarxio (filgrastim-sndz) in 2015.
According to Pfizer, “Nivestym is expected to be available in the US at a significant discount to the current wholesale acquisition cost of Neupogen.”
While Pfizer spokesperson Thomas Biegi did not disclose specific pricing or commercialisation strategies, he told us “the availability of biosimilars to the market will create competition and drive value.”
The approval comes just days after the FDA issued its Biosimilar Action Plan, as part of a greater strategy to encourage and reward biologics development, and promote biosimilar competition.
In response to the document, a Pfizer spokesperson told us: “The Biosimilars Action Plan is an important step forward to cultivating a robust biosimilars market in the US with the potential to improve the lives of millions of Americans.
“But more work needs to be done to tear down market barriers to biosimilars and it will require cooperation from a robust coalition of stakeholders: from Congress and insurers to the FDA, to biologics manufacturers, and the middle-men.”
The addition of Nivestym brings Pfizer’s biosimilar approval count to four in the US: Inflectra (infliximab) in 2016, Ixifi (infliximab-qbtx) in 2017 – both of which are alternatives to J&J’s Remicade – and its biosimilar version of Amgen’s Epogen, Retacrit (epoetin alfa-epbx), approved in May 2018.