The Food and Drug Administration (FDA) has approved Ziextenzo (pegfilgrastim-bmez; Sandoz), a biosimilar to Neulasta (pegfilgrastim; Amgen).

Ziextenzo, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

The approval was supported by data from a phase 1 study that demonstrated pharmacokinetic and pharmacodynamic similarity between the biosimilar and the reference product. Additionally, no clinically meaningful differences were observed with regard to safety and immunogenicity among treatment groups. 

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Ziextenzo will be supplied as 6mg/0.6mL preservative-free solution in a single-dose prefilled syringe for subcutaneous injection. The Company expects to launch Ziextenzo in the US possibly this year.

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