Vegzelma
ARTGs
Device/Product name
Vegzelma
Active Ingredient
Bevacizumab
Date of decision
Published
Submission type
New biosimilar medicine
ATC codes
LO1FG01
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) information submitted by the sponsor. The benefit-risk profile of Vegzelma was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
What steps were involved in the decision process?
Registration timeline
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
| Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced
| 30 November 2022 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 15 August 2023
|
| Advisory Committee meeting | Not applicable
|
| Registration decision (Outcome) | 30 August 2023
|
| Completion of administrative activities and registration on ARTG | 5 September 2023
|
| Number of working days from submission dossier acceptance to registration decision* | 138 |
* The COR-B process has a 175 working day evaluation and decision timeframe.
Date of entry onto ARTG
Black triangle scheme
No
Dose forms
Concentrate for solution for infusion
Strength
100 mg/4 mL and 400 mg/16 mL
Other ingredients
Polysorbate 20, dibasic sodium phosphate, purified water, trehalose dihydrate, monobasic sodium phosphate monohydrate
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous infusion
Pregnancy category
D
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage.
These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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 caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage.
These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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 is this medicine and how does it work
Bevacizumab is an antineoplastic agent containing the active ingredient, bevacizumab. Bevacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutralises the biologic activity of human vascular endothelial growth factor (VEGF).
Bevacizumab contains human framework regions with antigen binding regions of a humanised murine antibody that binds to VEGF. Bevacizumab is produced by recombinant deoxyribonucleic acid (DNA) technology in a Chinese hamster ovary mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.
Bevacizumab inhibits the binding of VEGF to its receptors, fms-like tyrosine kinase-1 (Flt-1) and kinase insert domain receptor (KDR), on the surface of endothelial cells. Neutralising the biologic activity of VEGF reduces the vascularisation of tumours, thereby inhibiting tumour growth. Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast, pancreas and prostate. Metastatic disease progression was inhibited and microvascular permeability was reduced.
Bevacizumab contains human framework regions with antigen binding regions of a humanised murine antibody that binds to VEGF. Bevacizumab is produced by recombinant deoxyribonucleic acid (DNA) technology in a Chinese hamster ovary mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.
Bevacizumab inhibits the binding of VEGF to its receptors, fms-like tyrosine kinase-1 (Flt-1) and kinase insert domain receptor (KDR), on the surface of endothelial cells. Neutralising the biologic activity of VEGF reduces the vascularisation of tumours, thereby inhibiting tumour growth. Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast, pancreas and prostate. Metastatic disease progression was inhibited and microvascular permeability was reduced.
What post-market commitments will the sponsor undertake
- Laboratory testing & compliance with Certified Product Details (CPD):
- All batches of Vegzelma bevacizumab 100 mg/4 mL and 400 mg/16 mL concentrate solution for intravenous infusion, vial 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: The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) [https://www.tga.gov.au/resources/resource/guidance/guidance-7-certified-product-details], 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.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by Searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.