Ziextenzo, a Biosimilar to Neulasta, Receives FDA Approval

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. 

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.

For more information visit us.sandoz.com.

This article originally appeared on MPR