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Ziextenzo
Published
Product name
Ziextenzo
Active ingredient
Pegfilgrastim
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ziextenzo (pegfilgrastim) was approved for the following therapeutic use:
Ziextenzo is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.
How this medicine works
Ziextenzo (pegfilgrastim) is a long-acting form of recombinant human granulocyte colony-stimulating factor (G-CSF). Ziextenzo is composed of recombinant human G-CSF (filgrastim) bound to a polyethylene glycol (PEG) molecule. Ziextenzo is a biosimilar medicine to Neulasta. Human G-CSF is a glycoprotein which regulates the production and release of neutrophils from the bone marrow. Pegfilgrastim has reduced renal clearance and prolonged persistence in vivo compared to filgrastim. Pegfilgrastim and filgrastim have been shown to have identical modes of action. They cause a marked increase in peripheral blood neutrophil counts within 24 hours in subjects with healthy bone marrow, with minor increases in monocytes and/or lymphocytes. Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Ziextenzo was considered favourable for the therapeutic use approved.
Sponsor