Pfizer receives FDA approval for Nivestym, a Neutropenia biosimilar

Pfizer Inc. has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for Nivestym (filgrastim-aafi), a biosimilar to Amgen’s Neupogen (filgrastim), for treating neutropenia. This approval is a crucial step in making effective treatments more accessible and affordable for patients suffering from this condition.

Neutropenia, characterized by an unusually low concentration of neutrophils, a type of white blood cell, is common in patients undergoing chemotherapy, those affected by radiation poisoning, HIV/AIDS, or due to unknown causes. Nivestym’s approval will provide patients, particularly those undergoing cancer treatment, a new, potentially more cost-effective option.

Nivestym marks the fourth biosimilar from Pfizer to receive FDA approval, highlighting the company’s ongoing commitment to expanding its portfolio in this area. Pfizer’s biosimilars pipeline includes 10 molecules, with five in mid-to-late stage clinical development, underscoring its strategic focus on biosimilars as pivotal components of modern healthcare.

The FDA’s approval of Nivestym was based on a comprehensive review of a complete data package, demonstrating a high degree of similarity between Nivestym and the reference drug, Neupogen. This review ensures that Nivestym meets the rigorous standards for safety, efficacy, and quality necessary for FDA approval.

Berk Gurdogan, U.S. Institutions President at Pfizer Essential Health, commented on the approval: “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. We believe biosimilars, like Nivestym, are essential in helping to address evolving healthcare needs and may provide more affordable medicines to patients.”

Pfizer has announced that Nivestym will be available in the U.S. at a significant discount compared to the wholesale acquisition cost (WAC) of Neupogen, though specific pricing details remain under wraps. This pricing strategy aims to make Nivestym a more accessible treatment option, reflecting Pfizer’s dedication to patient care and cost reduction in healthcare.

This approval not only enhances Pfizer’s standing in the biopharmaceutical field but also promises to impact the broader healthcare landscape by providing more affordable, effective treatment alternatives. As Pfizer continues to innovate and expand its biosimilar offerings, the healthcare community anticipates further advancements that will continue to support patient care and address critical health issues.