Filpegla
Sponsor
Device/Product name
Filpegla
Active Ingredient
Pegfilgrastim
Date of decision
Published
Submission type
New biosimilar medicine
ATC codes
L03AA13
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Filpegla was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 1 June 2021 |
| First round evaluation completed | 3 November 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 23 December 2021 |
| Second round evaluation completed | 18 February 2022 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 28 February 2022 |
| Sponsor’s pre-Advisory Committee response | 24 March 2022 |
| Advisory Committee meeting | 1 April 2022 |
| Registration decision (Outcome) | 1 August 2022 |
| Completion of administrative activities and registration on ARTG | 19 August 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 194 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
No
Dose forms
Solution for injection
Strength
6 mg/0.6 mL (10mg/mL)
Other ingredients
Glacial acetic acid, polysorbate 20, sodium hydroxide, sorbitol, water for injections.
Containers
Syringe
Pack sizes
One
Routes of administration
Subcutaneous
Dosage
The recommended dosage of Filpegla is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Filpegla should be administered approximately 24 hours after the administration of cytotoxic chemotherapy. In clinical studies, pegfilgrastim has been safely administered 14 days before chemotherapy (see Section 4.4 Special warnings and precautions for use).
For further information refer to the Product Information.
Pregnancy category
B3
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.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
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.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
What was approved
Filpegla (pegfilgrastim) was approved for the following therapeutic use:
Filpegla 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.
What is this medicine and how does it work
Filpegla is a biosimilar medicine to Neulasta.
Human granulocyte colony stimulating factor (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.
Human granulocyte colony stimulating factor (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.
What post-market commitments will the sponsor undertake
- Laboratory testing & compliance with Certified Product Details (CPD)
- All batches of Filpegla supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
- Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) http://www.tga.gov.au/industry/pm-argpm-guidance-7.htm, in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- Reports are to be provided in line with the current published list of European Union (EU) reference dates and frequency of submission of periodic safety update reports (PSURs) until the period covered by such reports is not less than three years from the date of the approval letter
- The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. The Periodic Safety Update Report (PSUR) will be submitted in 2022, when available.
- For all injectable products the Product Information must be included with the product as a package insert.