- The U.S. Food and Drug Administration (FDA) has accepted
Bio-Thera's Biologics License Applications (BLA) for BAT2206 as an
interchangeable biosimilar to reference product
Stelara®
- The European Medicines Agency (EMA) has accepted the Marketing
Authorization Application (MAA) for BAT2206 as a biosimilar to
reference product Stelara®
- The BAT2206 BLA and MAA are based on a robust analytical,
non-clinical and clinical data package comparing BAT2206 to the
reference product Stelara®
GUANGZHOU, China, July 24,
2024 /PRNewswire/ -- Bio-Thera
Solutions Inc. (688177:SH), a commercial-stage
biopharmaceutical company developing a pipeline of innovative
therapies and biosimilars, today announced that the FDA has
accepted the BLA for BAT2206, a proposed interchangeable biosimilar
to Stelara® (ustekinumab) seeking a commercial license
in the United States of America.
In addition, Bio-Thera also announced that the EMA has accepted the
MAA for BAT2206 seeking a commercial license in the European Union
(EU). A Biologics License Application seeking approval for BAT2206
is also currently under review by the China National Medicinal
Product Administration (NMPA).
![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. (PRNewsfoto/Bio-Thera Solutions, Ltd) 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. (PRNewsfoto/Bio-Thera Solutions, Ltd)](https://mma.prnewswire.com/media/2332090/3Bio_Thera_LOGO_Logo.jpg)
"The acceptance of both the FDA BLA and the EMA MAA for BAT2206
marks a milestone for Bio-Thera as it is the first ustekinumab
biosimilar developed by a Chinese company to be submitted to the
FDA or EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera
Solutions. "Bio-Thera is committed to helping patients around the
world in need of affordable therapeutics like ustekinumab by
developing BAT2206 for the global markets."
This BLA/MAA for BAT2206 is based on the totality of evidence
comprising a comprehensive analytical, non-clinical and clinical
data package. Extensive analytical characterization of the
structural, physicochemical, and biological properties of BAT2206
was conducted and supports biosimilarity with the reference
product. Additionally, a randomized
double-blind, single-dose, three-arm, parallel group
Phase 1 study compared the pharmacokinetics, safety and
immunogenicity of BAT2206 with both the EU and US reference
ustekinumab in healthy volunteers, while a randomized,
double-blind, multi-dose, three-arm, parallel group Phase 3 study
compared BAT2206 with ustekinumab to establish equivalent efficacy
and comparable pharmacokinetic, safety and immunogenicity profiles,
in subjects with Moderate to Severe Plaque Psoriasis.
About BAT2206 (ustekinumab)
BAT2206 is a proposed
biosimilar to Stelara® which is a human monoclonal
antibody that inhibits the bioactivity of human IL-12 and IL-23 by
preventing shared p40 from binding to the IL-12Rβ1 receptor protein
expressed on the surface of immune cells. IL-12 and IL-23 are
involved in inflammatory and immune responses, such as natural
killer cell activation and CD4+ T-cell differentiation and
activation. IL-12 and IL-23 have been implicated as important
contributors to the chronic inflammation that is a hallmark of
Crohn's disease and ulcerative colitis, among many other autoimmune
diseases. In the United States,
Stelara® is a currently approved treatment for adult
patients with 1) moderate to severe plaque psoriasis (PsO) who are
candidates for phototherapy or systemic therapy, 2) active
psoriatic arthritis (PsA), 3) moderately to severely active Crohn's
disease (CD), 4) moderately to severely active ulcerative
colitis. In pediatric patients 6 years and older
Stelara® is currently approved for the treatment of 1)
moderate to severe plaque psoriasis, who are candidates for
phototherapy or systemic therapy and 2) active psoriatic arthritis
(PsA).
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 in the US, EU and China, 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
antibody-drug conjugates (ADCs). For more information, please visit
www.bio-thera.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 BAT2206 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 challenges in obtaining 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.
- Stelara® is a registered trademark of Johnson &
Johnson Corporation
- QLETLI® is a registered trademark of Bio-Thera
Solutions, Ltd.
- TOFIDENCE™ is a trademark of Biogen
- Avzivi® is a registered trademark of Sandoz AG
- POBEVCY® is a registered trademark of Bio-Thera
Solutions, Ltd.
Contact
Bio-Thera Solutions,
Ltd.:
Bert E. Thomas IV +1.410.627.1734
bethomas@bio-thera.com
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SOURCE Bio-Thera Solutions, Ltd