-
TOFIDENCE is Bio-Thera’s first product
approved by USFDA.
-
TOFIDENCE is the first monoclonal antibody
drug researched, developed, and manufactured by a Chinese pharmaceutical
company to receive FDA approval in the United States
-
TOFIDENCE is the first biosimilar to
Actemra approved by USFDA
GUANGZHOU, China, October 8, 2023
/PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage
biopharmaceutical company developing a pipeline of biosimilars and innovative
assets, announced that its partner Biogen recently received notification from the
United States Food and Drug Administration (FDA) on the approval of TOFIDENCE (tocilizumab-bavi)
intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA.
The TOFIDENCE intravenous formulation is approved for the treatment of
moderately to severely active rheumatoid arthritis, polyarticular juvenile
idiopathic arthritis and systemic juvenile idiopathic arthritis.
TOFIDENCE (BAT1806 / BIIB800) is Bio-Thera’s
first FDA approved product in the United States, and the first biosimilar
developed and manufactured by a Chinese pharmaceutical company approved in the
United States.
Tocilizumab-bavi is a monoclonal antibody
that binds to interlukin-6 receptors and is used to treat various inflammatory
autoimmune conditions, including rheumatoid arthritis, polyarticular juvenile
idiopathic arthritis and systemic juvenile idiopathic arthritis.
“The approval of TOFIDENCE is a landmark
achievement for Bio-Thera as it marks Bio-Thera’s first FDA approval for a
product in the United States” said Shengfeng Li, CEO at Bio-Thera. “Bio-Thera
is committed to developing biosimilars for patients around the globe and this
approval demonstrates that commitment.”
Biogen and Bio-Thera entered into a partnership
agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Developed by
Bio-Thera, TOFIDENCE will be commercialized by Biogen in all countries
excluding China (including Hong Kong, Macau and Taiwan).
The FDA approval of TOFIDENCE was based on
a comprehensive analytical, non-clinical and clinical data package submitted by
Biogen to the FDA in Sept 2022. Extensive analytical characterization of the
structural, physicochemical, and biological properties of TOFIDENCE was
conducted and supports biosimilarity with the reference product. Additionally,
a randomized double-blind, single-dose, three-arm, parallel phase I study
compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both
the US and EU reference tocilizumab in healthy volunteers, while a randomized,
double-blind, multi-dose, three-arm parallel phase III study compared TOFIDENCE
with tocilizumab to establish equivalent efficacy and comparable
pharmacokinetic, safety and immunogenicity profiles, in subjects with
rheumatoid arthritis inadequately controlled by methotrexate. The totality of
evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.
About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), is a treatment
developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is
indicated for the treatment of moderate to severe rheumatoid arthritis,
polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic
arthritis.
Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely
active rheumatoid arthritis who have had an inadequate response to one or more
Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Polyarticular Juvenile Idiopathic Arthritis
(PJIA)
Patients 2 years of age and older with
active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis
(SJIA)
Patients 2 years of age and older with
active systemic juvenile idiopathic arthritis.
IMPORTANT SAFETY INFORMATION
The U.S. prescribing information for
TOFIDENCE includes a boxed WARNING for RISK OF SERIOUS INFECTIONS: Patients
treated with tocilizumab products including TOFIDENCE are at increased risk for
developing serious infections that may lead to hospitalization or death. Most
patients who developed these infections were taking concomitant
immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt
TOFIDENCE until the infection is controlled.
Reported infections include:
Active tuberculosis, which may present with
pulmonary or extrapulmonary disease. Patients should be tested for latent
tuberculosis before TOFIDENCE use and during therapy. Treatment for latent
infection should be initiated prior to TOFIDENCE use.
Invasive fungal infections, including
candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal
infections may present with disseminated, rather than localized, disease.
Bacterial, viral and other infections due
to opportunistic pathogens.
The risks and benefits of treatment with
TOFIDENCE should be carefully considered prior to initiating therapy in
patients with chronic or recurrent infection.
Patients should be closely monitored for
the development of signs and symptoms of infection during and after treatment
with TOFIDENCE, including the possible development of tuberculosis in patients
who tested negative for latent tuberculosis infection prior to initiating
therapy.
Contraindications
TOFIDENCE is contraindicated in patients
with known hypersensitivity to tocilizumab products.
Warnings and Precautions
Serious Infections - do not administer
TOFIDENCE during an active infection, including localized infections. If a
serious infection develops, interrupt TOFIDENCE until the infection is
controlled.
Gastrointestinal (GI) perforation - use
with caution in patients who may be at increased risk.
Hepatotoxicity - Monitor patients for signs
and symptoms of hepatic injury. Modify or discontinue TOFIDENCE if abnormal
liver tests persist or worsen or if clinical signs and symptoms of liver
disease develop.
Laboratory monitoring - recommended due to
potential consequences of treatment-related changes in neutrophils, platelets,
lipids, and liver function tests.
Hypersensitivity reactions, including
anaphylaxis and death have occurred.
Live vaccines - Avoid use with TOFIDENCE.
Adverse Reactions
Most common adverse reactions (incidence of
at least 5%): upper respiratory tract infections, nasopharyngitis, headache,
hypertension, increased ALT.
For additional Important Safety Information
on TOFIDENCE (tocilizumab-bavi), see full Prescribing
Information.
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®, POBEVCY®
and BAT1806 in 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.vidocn.com/en/or follow us on LinkedIn, X (@bio_thera_sol) and WeChat
(Bio-Thera).
Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain
forward-looking statements relating to TOFIDENCE (BAT1806) 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.
TOFIDENCE™ is a trademark of Biogen, Inc.
QLETLI® is a registered trademark of
Bio-Thera Solutions, Ltd.
POBEVCY® is a registered trademark of
Bio-Thera Solutions, Ltd.