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The US FDA Approves Pfizer's Oncology Supportive Care Biosimilar Nyvepria (biosimilar- pegfilgrastim)

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The US FDA Approves Pfizer's Oncology Supportive Care Biosimilar Nyvepria (biosimilar- pegfilgrastim)

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  • The EC has approved Nyvepria- a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
  • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
  • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

­ Ref: Pfizer | Image: Pfizer

Click here to­ read the full press release 

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