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Ziextenzo FDA Approval History

Last updated by Judith Stewart, BPharm on June 12, 2020.

FDA Approved: Yes (First approved November 4, 2019)
Brand name: Ziextenzo
Generic name: pegfilgrastim-bmez
Dosage form: Injection
Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy

Ziextenzo (pegfilgrastim-bmez) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

  • Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • The FDA approval of Ziextenzo was based on the results of a three-way study that compared Sandoz pegfilgrastim with US-sourced, and EU-sourced, reference pegfilgrastim. Clinical data demonstrated that Ziextenzo was biosimilar to the reference products, with similar pharmacokinetic and pharmacodynamic profiles, and no clinically meaningful differences in safety and immunogenicity.
  • Ziextenzo is administered subcutaneously via a single-dose prefilled syringe.
  • Patients should be made aware of the following risks associated with the use of Ziextenzo: splenic rupture and splenomegaly, acute respiratory distress syndrome, serious allergic reactions, sickle cell crises, glomerulonephritis, capillary leak syndrome, and aortitis.
  • Common adverse reactions include bone pain and pain in extremities.
  • Ziextenzo is the third FDA-approved pegfilgrastim biosimilar, after the approvals of Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb).

Development timeline for Ziextenzo

Nov  5, 2019Approval FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
Apr  3, 2019Sandoz Resubmits Biosimilar Pegfilgrastim Application to US FDA
Dec  8, 2017Sandoz Announces New Phase I Data Showing Proposed Biosimilar Pegfilgrastim Matches Reference Medicine

Further information

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