FDA Approves Second Biosimilar to Neupogen

This article originally appeared on The Center for Biosimilars.

The FDA on Friday approved Pfizer's filgrastim-aafi, a filgrastim biosimilar to Amgen's Neupogen. The product, the second filgrastim biosimilar approved in the United States, will be sold under the brand name Nivestym.

“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 hospitalized for potentially life-threatening side effects stemming from chemotherapy,” said Berk Gurdogan, US institutions president for Pfizer Essential Health, in a statement made to The Center for Biosimilars

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. “We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”

The drug is approved for the same indications as the reference product, including decreasing the incidence of infection due to neutropenia. Specifically, the drug has been approved to treat side effects from cancer treatment for patients:

• With acute myeloid leukemia receiving induction or consolidation chemotherapy
• With cancer receiving myelosuppressive chemotherapy
• With cancer undergoing bone marrow transplant
• Undergoing autologous peripheral blood progenitor cell collection and therapy
• With severe chronic neutropenia

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