Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug Administration (FDA) has approved Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®.
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[07-December-2023] |
GUANGZHOU, China, Dec. 7, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today announced that the United States Food and Drug Administration (FDA) has approved Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®. Avzivi® is Bio-Thera’s second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States. The FDA approval of Avzivi® was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA. Extensive analytical characterization between BAT1706 and US and EU Avastin® was conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706. A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of BAT1706 with both the US and EU Avastin® in healthy volunteers. A randomized, double-blind, three-arm parallel phase III study compared BAT1706 with Avastin® for efficacy, safety, and immunogenicity in subjects with advanced non-squamous non-small cell lung cancer. The totality of the evidence demonstrated that BAT1706 has similar efficacy, safety, immunogenicity and quality as the reference product bevacizumab. “Bevacizumab has been widely used in the treatment for lung and colorectal cancers and many other cancers around the world,” commented professor Li Zhang, 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.” 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. About Avzivi® (bevacizumab-tnjn) About Bio-Thera Solutions Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to Avzivi®/BAT1706 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include those associated with regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.
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Company Codes: Shanghai:688177 |