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Abevmy

15 September 2021

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

Summary of submission

Submission type
New biosimilar medicine
Product name
Abevmy
Active ingredients
Bevacizumab
ATC codes
L01XC07
Decision
Approved
Date of decision
10 May 2021
Date of entry onto ARTG
6 September 2021
Original publication date
15 September 2021
ARTG numbers
334814, 334816
Black Triangle Scheme
No
Sponsor
Alphapharm Pty Ltd
Sponsor address
Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000
Dose forms
Injection, concentrated
Strength
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
Containers
Vial
Pack sizes
1
Routes of administration
Intravenous infusion
Dosage

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

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.

What was approved?

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.

Cervical cancer

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.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • 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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.