Pfizer Receives the US FDA’s Approval for its Nyvepria (biosimilar, pegfilgrastim)

Shots:

• 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