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Pfizer Receives the US FDA's Approval for its Nyvepria (biosimilar- pegfilgrastim)

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Pfizer Receives the US FDA's Approval for its Nyvepria (biosimilar- pegfilgrastim)

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  • The US FDA has approved Nyvepria (pegfilgrastim-apgf) to decrease the incidence of infection- as manifested by febrile neutropenia- in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapies associated with a clinically significant incidence of febrile neutropenia
  • The approval is based on the comprehensive data package and totality of evidence demonstrating a high bio similarity of Nyvepria to its reference product- Neulasta. The approval provides clinicians with an additional long-acting treatment option that can prevent infections in patients undergoing myelosuppressive CT
  • Following the launch- patients will have access to Pfizer Oncology Together which offers personalized support to patients accessing their prescribed Pfizer Oncology medications. Additionally- the regulatory approval with EMA is under review

Click here to read full press release/ article | Ref: Pfizer | Image: Pharmaceutical Technology


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