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FDA approves Pfizer biosimilar version of Amgen’s Neupogen

pharmafile | July 23, 2018 | News story | Sales and Marketing Amgen, FDA, Neupogen, Nivestym, Pfizer, pharma 

The FDA has announced its decision to approve Pfizer’s Nivestym, the firm’s biosimilar version of Amgen’s Neupogen (filgrastim), for use in the US under all the indications previously secured by the originator product.

The decision, which marks the fourth biosimilar approval for the US manufacturer, was based on “a review of a comprehensive data package and totality of evidence” which indicated Nivestym’s safety and efficacy profile to be highly comparable to its reference product.

Just like Neupogen, Nivestym is approved for a range of purposes including the treatment of neutropenia and neutropenia-related sequelae in patients with various forms of the condition, as well as in acute myeloid leukaemia and other diseases.

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“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 at 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.”

Matt Fellows

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