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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|| |
16 January 2019
|Date of entry onto ARTG|| |
30 June 2020
|ARTG numbers|| |
|Black Triangle Scheme|| |
Amgen Australia Pty Ltd
|Sponsor address|| |
Level 7, 123 Epping Road, North Ryde, NSW 2113
|Dose forms|| |
100 mg/4 mL or 400 mg/16 mL
|Other ingredients|| |
Trehalose dehydrate, monobasic sodium phosphate, dibasic sodium phosphate, polysorbate 20, water for injections
|Pack sizes|| |
|Routes of administration|| |
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient dispensing record.
Mvasi should be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products.
Dosage of Mvasi is based on multiple factors, including the type of cancer and the body weight of the patient.For further information refer to the Product Information.
|Pregnancy category|| |
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.
Mvasi (bevacizumab) was approved for the following therapeutic use:
Metastatic colorectal cancer
Mvasi (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.
Locally recurrent or metastatic breast cancer
Mvasi (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated. (see section 5.1 Pharmacodynamic properties, Clinical trials).
Advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
Mvasi (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non‑squamous, non-small cell lung cancer.
Advanced and/or metastatic renal cell cancer
Mvasi (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.
Grade IV glioma
Mvasi (bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV glioma after relapse or disease progression after standard therapy, including chemotherapy.
Epithelial ovarian, fallopian tube or primary peritoneal cancer
Mvasi (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
Mvasi (bevacizumab), in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.
Mvasi (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.
Mvasi (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. Mvasi (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.
Mvasi is a biosimilar medicine to Avastin (bevacizumab).
Mvasi is an anti-neoplastic 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 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-related 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.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||1 February 2018|
|First round evaluation completed||29 June 2018|
|Sponsor provides responses on questions raised in first round evaluation||3 September 2018|
|Second round evaluation completed||9 October 2018|
|Delegate's overall benefit-risk assessment||12 November 2018|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||16 January 2019|
|Completion of administrative activities and registration on ARTG||30 June 2020|
|Number of working days from submission dossier acceptance to registration decision*||187|
*Statutory timeframe for standard applications is 255 working days
- The ABP 215 (bevacizumab biosimilar) European Union-Risk Management Plan (EU-RMP) (Version 0.3; dated 29 September 2017; data lock point (DLP) 10 September 2015), with Mvasi Australian specific Annex (Version 3.0; dated 16 August 2018), included with submission PM-2017-04616-1-4, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of 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 (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- Batch release testing and compliance with Certified Product Details (CPD)
- It is a condition of registration that all batches of Mvasi (bevacizumab) imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the CPD.
- It is a condition of registration that each batch of Mvasi (bevacizumab) imported into Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories branch. Outcomes of laboratory testing are published biannually in the TGA database of laboratory testing results.
- The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry.Testing@health.gov.au for specific material requirements related to the batch release testing/assessment of the product. More information is available at TGA testing of biological medicines
This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation.
- Certified Product Details
The CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), 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.
- For all injectable products the Product Information (PI) must be included with the product as a package insert.