On December 7, the Guangzhou, China–based manufacturer Bio-Thera Solutions announced that it had received FDA approval for its bevacizumab biosimilar. Dubbed Avzivi® (bevacizumab-tnjn), the agent will be marketed (globally) by Sandoz.
The drug is indicated for:
- 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. (Limitation of Use: 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
The biologic licensing application for BAT1706 (the original investigational name for the agent) included the results of a phase 3 comparative trial with Avastin® in patients with nonsquamous, non–small cell lung cancer. The 351(k) application was originally filed in December 2020. Information was not publicly reported as to the cause of the much-delayed decision.
Avzivi will be the fifth bevacizumab biosimilar to enter the market; biosimilars have approximately 85% of the US bevacizumab marketshare, according to the latest figures.
Bio-Thera’s Avzivi approval comes on the heels of its Actemra® biosimilar—Tofidence®—FDA approval on October 2.