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Onbevzi (bevacizumab)
Published
Product name
Onbevzi
Active ingredient
Bevacizumab
Submission type
New Biosimilar
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Onbevzi (bevacizumab) was approved for the following therapeutic use:
Metastatic Colorectal Cancer
Onbevzi (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.
Locally recurrent or metastatic Breast Cancer
Onbevzi (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 Clinical Trials).
Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC)
Onbevzi (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
Onbevzi (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.
Grade IV Glioma
Onbevzi (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
Onbevzi (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 Onbevzi (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.
Onbevzi (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
Onbevzi (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. Onbevzi (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.
How this medicine works
Onbevzi is a biosimilar medicine to Avastin (bevacizumab). Bevacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutralises the biologic activity of human vascular endothelial growth factor (VEGF) by binding to its receptors, Flt-1 and KDR, on the surface of endothelial cells. Neutralising the biologic activity of VEGF reduces blood vessel formation in tumours, thereby inhibiting tumour growth. Administration of bevacizumab to mice transplanted with human tumour cells resulted in extensive anti-tumour activity, including against colon, breast, pancreas and prostate cancer cells. Microvascular permeability (blood vessel "leakiness") was reduced potentially resulting in inhibition of metastatic disease (when tumour cells break away from the primary site, travel through the blood or lymph system, and form new tumors at a new site in the body).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Onbevzi was considered favourable for the therapeutic use approved.
A Phase I study in healthy male subjects demonstrated the similarity between Onbevzi and Avastin in terms of pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) while the steady-state serum concentration data in a clinical Phase III study provided evidence for the pharmacokinetic similarity in a representative patient population (metastatic or recurrent non-squamous NSCLC). The ability of Onbevzi to exert the same therapeutic effect and have the same safety profile as EU Avastin was demonstrated in a clinical Phase III study where Onbevzi and EU Avastin were compared in patients with metastatic or recurrent non-squamous NSCLC using "the overall response rate (ORR)" as the study endpoint. The ORR was equivalent in both groups.
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