Pfizer bags approval for Neupogen biosimilar
Pfizer’s Neupogen biosimilar Nivestym has been approved by the US Food and Drug Administration and is expected to hit the market at a “significant discount” to its reference drug.
The white blood cell stimulator will be available for all eligible indications of Amgen’s Neupogen (filgrastim), such as decreasing the incidence of infection in some cancer patients, after showing “a high degree of similarity” in clinical trials, the drug giant said.
“The FDA approval of Nivestym marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalised for potentially life-threatening side effects stemming from chemotherapy,” noted Berk Gurdogan, US Institutions president, Pfizer Essential Health.
“We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”
Nivestym is expected to be available in the US “at a significant discount: to the current wholesale acquisition cost of Neupogen, according to Pfizer, though the drug will be competing for market share with Novartis’ Neupogen biosimilar Zarxio, which became the first biosimilar to be approved by the US Food and Drug Administration back in March 2015.