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Pfizer's Nivestym (filgrastim-aafi- biosmilar) Receives the US FDA Approval for Neutropenia

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Pfizer's Nivestym (filgrastim-aafi- biosmilar) Receives the US FDA Approval for Neutropenia

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  • The approval is based on non-inferiority data demonstrating biosimilarity between Nivestym and the reference product- Neupogen (filgrastim)
  • Pfizer has received the US FDA’s fourth approvals for its biosimilar including Nivestym and will be available at a discount of wholesale acquisition cost (WAC) of Neupogen
  • Nivestym (filgrastim-aafi- Neupogen) is a mAb- indicated to decrease the incidence of infection due to febrile neutropenia- reducing the time to neutrophil recovery & neutropenia and for reduction in incidence and duration of sequelae of severe neutropenia

Ref: Kyowa Kirin | Image: Philly

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