Biosimilar Nyvepria Gets FDA Approval

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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.

Nyvepria is the fourth pegfilgrastim biosimilar approved by the FDA. Other approved biosimilars include Fulphila (Mylan), Udenyca (Coherus Biosciences), and Ziextenzo (Sandoz).

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