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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|| |
10 May 2021
|Date of entry onto ARTG|| |
6 September 2021
|Original publication date|| |
15 September 2021
|ARTG numbers|| |
|Black Triangle Scheme|| |
Alphapharm Pty Ltd
|Sponsor address|| |
Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000
|Dose forms|| |
100 mg/4 mL and 400 mg/16 mL
|Other ingredients|| |
Trehalose dihydrate, monobasic sodium phosphate dihydrate, dibasic sodium phosphate, polysorbate 20 and water for injections
|Pack sizes|| |
|Routes of administration|| |
Dosage of Abevmy is based on multiple factors, including the condition being treated, the body weight of the patient and whether the medicine is used as first or second line treatment.
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.
Abevmy (bevacizumab) was approved for the following therapeutic use:
Metastatic colorectal cancer
Abevmy (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.
Locally recurrent or metastatic breast cancer
Abevmy (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)
Abevmy (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer. Advanced and/or metastatic renal cell cancer Abevmy (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.
Grade IV glioma
Abevmy (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
Abevmy (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for firstline 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
Abevmy (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.
Abevmy (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.
Abevmy (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. Abevmy (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.
Abevmy is a biosimilar medicine to Avastin.
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 DNA technology in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin and is purified by a process that includes specific viral inactivation and removal steps. Gentamicin is detectable in the final product at ≤ 0.35 parts per million (ppm).
Bevacizumab inhibits the binding of VEGF to its receptors, fms-like tyrosine kinase-1 (Flt-1) and kinase-insert domain containing 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||2 June 2020|
|First round evaluation completed||2 November 2020|
|Sponsor provides responses on questions raised in first round evaluation||4 January 2021|
|Second round evaluation completed||17 February 2021|
|Delegate's overall benefit-risk assessment||4 May 2021|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||10 May 2021|
|Completion of administrative activities and registration on ARTG||6 September 2021|
|Number of working days from submission dossier acceptance to registration decision*||193|
*Statutory timeframe for standard applications is 255 working days
- This approval does not impose any requirement for the submission of periodic safety update reports (PSURs). The sponsor should note that it is a requirement that all existing requirements for the submission of PSURs as a consequence of the initial registration or subsequent changes must be completed.
- Laboratory testing & compliance with Certified Product Details
All batches of Abevmy (bevacizumab) 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 and periodically in testing reports on the TGA website.
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 must be included with the product as a package insert.