FDA Approves Avzivi, the Fifth Biosimilar to Avastin

Avzivi was approved with 7 oncology indications.

The FDA has approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer.

Avzivi is a humanized monoclonal antibody that inhibits vascular endothelial growth factor and references Genentech’s Avastin (bevacizumab). The biosimilar is also the second product developed by Bio-Thera Solutions, a Guangzhou, China-based pharmaceutical company, to receive FDA approval.

The biosimilar is approved for 7 indications, including:

• 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
• Nonsquamous 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
• 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.

The approval was based on a data package containing results from nonclinical and clinicals trials to compare the safety and efficacy of Avzivi (BAT1706) and the US- and EU-sourced reference product.

During a randomized double-blind phase 1 trial, the pharmacokinetics, safety, and immunogenicity of BAT1706 were evaluated in healthy volunteers, comparing it with both US and EU Avastin. Following this, a randomized double-blind phase 3 study with 3 arms investigated the efficacy, safety, and immunogenicity of BAT1706 in individuals with advanced non-squamous non-small cell lung cancer, comparing it to Avastin. The combined results from these studies provide compelling evidence that BAT1706 demonstrates efficacy, safety, immunogenicity, and quality similar to the reference product bevacizumab.

"Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world," said Li Zhang, PhD, leading investigator for global phase 3 study of Avzivi. "The global phase III clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety and immunogenicity. The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option. We hope Bio-Thera continues to make more high-quality biosimilars available to patients around the world."

When it launches, the product will be marketed by Sandoz as part of a September 2021 license and commercialization agreement for BAT1706. Under the terms of the agreement, Bio-Thera is responsible for development and manufacturing of the biosimilar. Sandoz also has the commercialization rights is all countries outside the United States.