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.
