Avzivi® (BAT1706) is Bio-Thera Solution’
second FDA approved product in the United States
Avzivi® is the second biosimilar researched,
developed, and manufactured by a Chinese pharmaceutical company to receive FDA
approval in the United States
Guangzhou, China – December 7, 2023 – 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)
Avzivi® (bevacizumab-tnjn) is a humanized
monoclonal antibody that targets VEGF. It specifically binds to VEGF and blocks
the binding of VEGF to its receptor, thereby reducing neovascularization,
inducing the degradation of existing blood vessels, and thereby inhibiting
tumor growth. The original company name for Avzivi® is BAT1706. In the United States, 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. (Limitation of Use: not indicated for
adjuvant treatment of colon cancer), 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, 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.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading
innovative, global biopharmaceutical company in Guangzhou, China, is dedicated
to researching and developing novel therapeutics for the treatment of cancer,
autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs,
as well as biosimilars for existing, branded biologics to treat a range of
cancer and autoimmune diseases. As a leader in next generation antibody
discovery and engineering, the company has advanced multiple candidates into
late-stage development, including three approved products: QLETLI® in China, and
TOFIDENCE™/ BAT1806 and Avzivi® /Pobevcy® in the US and China. In addition, the
company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology
in the post-PD-1 era and targeted therapies such as ADCs. For more information,
please visit www.mjtiyu.com/en/or follow us on Twitter (@bio_thera_sol) and
WeChat (Bio-Thera).
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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Avzivi® is a registered trademark of
Novartis AG
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Avastin® is a registered trademark of
Genentech, Inc.
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QLETLI® is a registered trademark of
Bio-Thera Solutions, Ltd.
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POBEVCY® is a registered trademark of
Bio-Thera Solutions, Ltd.
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TOFIDENCE™ is a trademark of Biogen, Inc.
