Nivestym gets FDA approval

In March 2015 the FDA approved Novartis’ Neupogen biosimilar Zarxio. Now it has approved a second biosimilar, Pfizer’s white blood cell stimulator Nivestym, which is expected to be available in the US much cheaper than Amgen’s Neupogen (filgrastim). Nivestym will be available to treat patients with neutropenia and for all eligible indications of Amgen’s Neupogen following clinical trials that showed there was a lot of similarity in the products.
Berk Gurdogan, US Institutions president, Pfizer Essential Health, 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. We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”