The Food and Drug Administration (FDA) has approved Nyvepria™ (pegfilgrastim-apgf; Pfizer), a biosimilar to Neulasta (pegfilgrastim; Amgen).
Nyvepria, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The approval was based on the review of comprehensive data demonstrating a high degree of similarity of Nyvepria to the reference product. The product will be available as 6mg/0.6mL preservative-free solution in single-dose prefilled syringes for subcutaneous injection. The Company expects to launch Nyvepria later this year.