Supportive care biosimilar Nyvepria approved by FDA

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Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim), received FDA approval.

Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Nyvepria is sponsored by Pfizer.

The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

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