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FDA Approves Pfizer's NIVESTYM™ (filgrastim-aafi)

On July 20, 2018, Pfizer announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.

“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, U.S. 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.”

The FDA approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NIVESTYM compared to its reference product.

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