Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and
Drug Administration (FDA) has approved 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 is the first tocilizumab biosimilar approved in the
United States. Biosimilars are biologic products that have been
demonstrated to have equivalent efficacy and comparable safety as
the approved reference product, with the advantage that they may
offer cost savings and promote expanded and sustainable access to
therapies. Spending on therapies for autoimmune diseases has
consistently increased by 10%–25% each year over the past decade1.
Since biosimilar entry in the US, medicines with biosimilar
competition have experienced greater patient adoption equaling more
than 150 million days of patient therapy1.
“The approval of TOFIDENCE in the U.S. marks another positive
step toward helping more people with chronic autoimmune conditions
gain access to leading therapies,” said Ian Henshaw, Global Head of
Biosimilars at Biogen. “With the increasing numbers of approved
biosimilars, we expect increased savings and sustainability for
healthcare systems and an increase in physician choice and patient
access to biologics.”
Biogen and Bio-Thera entered into a commercialization and
license agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021.
Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen
in the United States. Under the agreement, Biogen has exclusive
regulatory, manufacturing, and commercial rights to TOFIDENCE in
all countries excluding China (including Hong Kong, Macau and
Taiwan). Biogen is currently evaluating the potential launch
timeline for TOFIDENCE in the U.S.
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 moderately to severely active rheumatoid arthritis,
polyarticular juvenile idiopathic arthritis and systemic juvenile
idiopathic arthritis.
IndicationsRheumatoid 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 INFORMATIONThe 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.
ContraindicationsTOFIDENCE is contraindicated
in patients with known hypersensitivity to tocilizumab
products.
Warnings and PrecautionsSerious 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 ReactionsMost 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 BiogenFounded in 1978, Biogen is a
leading global biotechnology company that has pioneered multiple
breakthrough innovations including a broad portfolio of medicines
to treat multiple sclerosis, the first approved treatment for
spinal muscular atrophy, and two co-developed treatments to address
a defining pathology of Alzheimer’s disease. Biogen is advancing a
pipeline of potential novel therapies across neurology,
neuropsychiatry, specialized immunology and rare diseases and
remains acutely focused on its purpose of serving humanity through
science while advancing a healthier, more sustainable and equitable
world.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social
media - X, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor This news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, relating to the potential benefits,
safety and efficacy of TOFIDENCE; potential benefits of our
collaboration with Bio-Thera; risks and uncertainties associated
with drug development and commercialization; the potential of
Biogen’s commercial business and pipeline programs; Biogen’s
strategy and plans; and potential cost healthcare savings related
to biosimilars. These forward-looking statements may be accompanied
by words such as “aim,” “anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” “would” and other words and terms
of similar meaning. Drug development and commercialization involve
a high degree of risk, and only a small number of research and
development programs result in commercialization of a product.
Results in early stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements or the scientific data
presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, risks that risks of
unexpected costs or delays or other unexpected hurdles; uncertainty
of success in the commercialization of TOFIDENCE, which may be
impacted by, among other things, unexpected concerns that may arise
from additional data or analysis, the occurrence of adverse safety
events, failure to obtain regulatory approvals in certain
jurisdictions, failure to protect and enforce data, intellectual
property and other proprietary rights and uncertainties relating to
intellectual property claims and challenges; risks of legal
actions, regulatory scrutiny or other challenges to biosimilars;
the direct and indirect impacts of the ongoing COVID-19 pandemic on
Biogen’s business, results of operations and financial condition;
the risks of doing business internationally, including currency
exchange rate fluctuations; product liability claims; and third
party collaboration risks. The foregoing sets forth many, but not
all, of the factors that could cause actual results to differ from
Biogen’s expectations in any forward-looking statement. Investors
should consider this cautionary statement, as well as the risk
factors identified in Biogen’s most recent annual or quarterly
report and in other reports Biogen has filed with the U.S.
Securities and Exchange Commission. These statements are based on
Biogen’s current beliefs and expectations and speak only as of the
date of this news release. Biogen does not undertake any obligation
to publicly update any forward-looking statements.
References:
- Association for Accessible
Medicines. The U.S. Generic & Biosimilars Medicines Savings
Report, September 2022.
https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf
Accessed August 2023.
MEDIA CONTACT:BiogenJack Cox+ 1 781 464
3260public.affairs@biogen.com |
INVESTOR CONTACT:BiogenChuck Triano+1 781 464
2442IR@biogen.com |
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