Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod


Nivestym FDA approval : Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Nivestym (filgrastim-aafi) – a biosimilar to Neupogen (filgrastim) for all eligible indications of the reference Amgen neutropenia drug.

Filgrastim is indicated in the US for neutropenia treatment among others. Neutropenia or low blood neutrophils, is a condition in which there will be an unusually low concentration of the type of white blood cells in the blood.

Neutropenia can occur after chemotherapy, radiation poisoning, HIV/AIDS, or unknown causes.

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Pfizer’s Nivestym is its fourth biosimilar to get an FDA approval. The US pharma giant’s biosimilars pipeline comprises 10 biosimilar molecules with five assets, currently in mid-to-late stage clinical development.

Pfizer bags Nivestym FDA approval for Amgen neutropenia drug Neupogen biosimilar

Pfizer bags Nivestym FDA approval for Amgen neutropenia drug Neupogen biosimilar. Photo courtesy of w:ru:jenix89 (talk | contribs) and

Nivestym FDA approval was based on a review by the US pharma regulator of a complete data package and totality of evidence which proved a high extent of similarity of the Pfizer biosimilar compared to the reference Amgen neutropenia drug.

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Commenting on Nivestym FDA approval, Berk Gurdogan – U.S. 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 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.”

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Pfizer said that Nivestym is likely to be available in the US at a considerable discount to the current wholesale acquisition cost (WAC) of the Amgen neutropenia drug Neupogen. The pharma major added that WAC does not include discounts to payers, providers, distributors and also other purchasing organizations.

Earlier this month, Pfizer along with Astellas Pharma secured cancer drug Xtandi FDA approval which has been also indicated to be used for treatment of non-metastatic castration-resistant prostate cancer (CRPC) in male patients.

For more pharma regulatory news like the Nivestym FDA approval, keep following

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