Bio-Thera Solutions obtains FDA OK for Avastin biosimilar
Bio-Thera Solutions has received the Food and Drug Administration’s green light for Avzivi (bevacizumab-tnjn), which is a biosimilar of Avastin.
Avzivi is Bio-Thera's second FDA approved product and is the second biosimilar researched, developed and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States.
"Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world," said Li Zhang, professor and leading investigator for global phase III 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."
"The approval of Avzivi is another landmark accomplishment for Bio-Thera as it marks Bio-Thera's second FDA approved product in the United States," said Shengfeng Li, CEO at Bio-Thera. "As our biosimilar pipeline continues to mature, we intend to seek more approvals of biosimilars, expanding patient access to important therapies."
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Bio-Thera and Sandoz entered into a license and commercialization agreement for Avzivi (BAT1706) in September 2021. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product. Sandoz is responsible for the commercialization of Avzivi in the United States and other countries around the world.
Avzivi is indicated for the treatment of 1) Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment; 2) 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; 3) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment; 4) Recurrent glioblastoma in adults; 5) Metastatic renal cell carcinoma in combination with interferon alfa; 6) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan; and 7) 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.
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