Avzivi FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 11, 2023.
FDA Approved: Yes (First approved December 6, 2023)
Brand name: Avzivi
Generic name: bevacizumab-tnjn
Dosage form: Injection
Company: Bio-Thera Solutions, Ltd.
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Avzivi is a vascular endothelial growth factor inhibitor biosimilar to Avastin used for the treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Avzivi is indicated for the treatment of:
- metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
- metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for
second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: Avzivi is not indicated for adjuvant treatment of colon cancer.
- unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
- recurrent glioblastoma in adults.
- metastatic renal cell carcinoma in combination with interferon alfa.
- persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
- epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. - FDA approval of Avzivi was based on analytical, non-clinical and clinical data that demonstrated that Avzivi is highly similar to Avastin, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Avzivi is administered via intravenous infusion over 90 minutes for the first infusion, over 60 minutes for the second infusion if the first infusion is tolerated, and over 30 minutes for subsequent infusions if the second infusion over 60 minutes is tolerated.
- Warnings and precautions associated with Avzivi include gastrointestinal perforations and fistula; surgery and wound healing complications; hemorrhage; arterial and venous thromboembolic events; hypertension; posterior reversible encephalopathy syndrome; renal injury and proteinuria; infusion-related reactions; embryo-fetal toxicity; ovarian failure; and congestive heart failure.
- Common adverse reactions include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
- Avzivi is the fifth approved biosimilar for Avastin following Mvasi (bevacizumab-awwb) in 2017, Zirabev (bevacizumab-bvzr) in 2019, and Alymsys (bevacizumab-maly) and Vegzelma (bevacizumab-adcd) in 2022.
Development timeline for Avzivi
Further information
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