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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biosimilar medicine
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
9 July 2019
|Date of entry onto ARTG|| |
6 September 2019
|Original publication date|| |
2 October 2019
|ARTG numbers|| |
|Black Triangle Scheme|| |
Sandoz Pty Ltd
|Sponsor address|| |
54 Waterloo Road, Macquarie Park NSW 2113
|Dose forms|| |
Solution for injection
6 mg/0.6 mL
|Other ingredients|| |
The product is formulated at pH 4.0 with 0.36 mg acetic acid, 30 mg sorbitol, 0.02 mg polysorbate 20, sodium hydroxide (if necessary for pH adjustment) in Water for Injection to 0.6 mL.
Prefilled syringe with automatic needle guard
|Pack sizes|| |
|Routes of administration|| |
The recommended dosage of Ziextenzo is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle, approximately 24 hours after the administration of cytotoxic chemotherapy.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
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.
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.
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.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||28 September 2018|
|First round evaluation completed||29 April 2019|
|Sponsor provides responses on questions raised in first round evaluation||3 May 2019|
|Second round evaluation completed||31 May 2019|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||1 July 2019|
|Sponsor's pre-Advisory Committee response||N/A|
|Advisory Committee meeting||N/A|
|Registration decision (Outcome)||9 July 2019|
|Completion of administrative activities and registration on ARTG||6 September 2019|
|Number of working days from submission dossier acceptance to registration decision*||153|
*Statutory timeframe for standard applications is 255 working days
For all injectable products the Product Information must be included with the product.