- SIMLANDI is the first citrate-free, high-concentration
biosimilar to be designated interchangeable to Humira in the
U.S.
- SIMLANDI is the first biosimilar approval under the strategic
partnership between Alvotech and Teva in the U.S. market
- SIMLANDI will qualify for interchangeable exclusivity in
the U.S. for some concentration strengths
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S.
affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:
TEVA), today announced that the U.S. Food and Drug Administration
(FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an
interchangeable biosimilar to Humira, for the treatment of adult
rheumatoid arthritis, juvenile idiopathic arthritis, adult
psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease,
adult ulcerative colitis, adult plaque psoriasis, adult
hidradenitis suppurativa and adult uveitis. In 2023, Humira was one
of the highest grossing pharmaceutical products in the world, with
sales in the U.S. of nearly $12.2 billion[1]. Teva is Alvotech’s
strategic partner for the exclusive commercialization of SIMLANDI
in the United States.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240223653457/en/
SIMLANDI is the first high-concentration, citrate-free
biosimilar to Humira that has been granted an interchangeability
status by the FDA, and will qualify for interchangeable exclusivity
for the 40mg/0.4ml injection. While both low-concentration and
high-concentration strength biosimilars of Humira are marketed in
the U.S. today, nearly 88 percent of U.S. prescriptions for
adalimumab are for the high-concentration presentation[2].
An interchangeable biosimilar may be substituted at the pharmacy
without consulting the prescriber, much like generic drugs are
routinely substituted for brand name drugs. As the only
interchangeable adalimumab biosimilar with the high-concentration
formulation, SIMLANDI can be substituted for Humira at the pharmacy
level, subject to state pharmacy laws.
"The approval of SIMLANDI marks the first high-concentration,
citrate-free biosimilar to Humira with IC status,” said Dr. Eric
Hughes, Executive Vice President Global R&D and Chief Medical
Officer at Teva. "Biosimilars create opportunities for cost savings
across the healthcare system and introduce additional treatment
options for patients. This approval marks an important milestone
for Teva and Alvotech’s partnership to collaborate on seven
biosimilars and expand the availability, access, and uptake of
biosimilars in the U.S.”
Robert Wessman, Chairman and CEO of Alvotech, added, “This
approval is an important milestone in Alvotech’s journey to offer
broader access worldwide to more affordable biologics, following
approvals of our biosimilars in other global markets. We strongly
believe that biosimilars are important in addressing inflationary
pressures in the healthcare system across all markets, especially
in the U.S. where biologics represent well over 40 percent of all
pharmaceutical spending. An interchangeable citrate-free,
high-concentration biosimilar adalimumab has the potential to
change the market dynamics in a rapidly evolving environment for
biosimilars in the U.S.”
In August 2020, Alvotech and Teva entered into a strategic
partnership for the exclusive commercialization of five of
Alvotech’s biosimilar product candidates, and in August 2023 the
partners extended the partnership to include two additional
biosimilars and two new presentations of previously partnered
products. Alvotech handles development and manufacturing, and Teva
is responsible for U.S. commercialization, which leverages Teva’s
extensive experience and sales and marketing infrastructure.
SIMLANDI is the first interchangeable, high-concentration,
citrate-free biosimilar approved under the strategic partnership.
Both Alvotech and Teva expect to launch SIMLANDI in the U.S.
imminently with interchangeability designation.
The FDA approval of SIMLANDI was based on a totality of
evidence, including analytical, non-clinical, and clinical data.
The clinical development program, included data from (i)
AVT02-GL-101, a Phase I, multicenter, randomized, double blind,
3-arm study, to demonstrate pharmacokinetic (PK) similarity and
compare safety and tolerability of SIMLANDI to Humira in healthy
adult volunteers; (ii) AVT02-GL-301, Phase III, multicenter,
double-blind, randomized, parallel-group active control study to
demonstrate similar efficacy, and compare safety and immunogenicity
of AVT02 versus Humira in patients with moderate-to-severe chronic
plaque psoriasis and (iii) AVT02-GL-302, a Phase III, multicenter,
randomized, double-blind, parallel-group study in moderate to
severe chronic plaque psoriasis patients to demonstrate similar PK,
and comparable efficacy, safety, and immunogenicity between
patients receiving Humira and patients undergoing repeated switches
between Humira and SIMLANDI.
Sources
[1] (AbbVie Full-Year and Fourth Quarter 2023 Financial
Results):
https://investors.abbvie.com/static-files/831c0d3d-8813-4942-b7af-a3dade33bea5
[2] Based on sales data from Symphony
Use of Trademarks
Humira® is a registered trademark of AbbVie Biotechnology
Ltd.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman,
focused solely on the development and manufacture of biosimilar
medicines for patients worldwide. Alvotech seeks to be a global
leader in the biosimilar space by delivering high quality,
cost-effective products, and services, enabled by a fully
integrated approach and broad in-house capabilities. Alvotech’s
current pipeline includes eight disclosed biosimilar candidates
aimed at treating autoimmune disorders, eye disorders,
osteoporosis, respiratory disease, and cancer. Alvotech has formed
a network of strategic commercial partnerships to provide global
reach and leverage local expertise in markets that include the
United States, Europe, Japan, China, and other Asian countries and
large parts of South America, Africa and the Middle East.
Alvotech’s commercial partners include Teva Pharmaceuticals, a US
affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA
Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma
(EEA, UK, Switzerland, Canada, Australia and New Zealand),
Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South
Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River
Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong,
Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and
Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi
Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs,
Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co.,
Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each
commercial partnership covers a unique set of product(s) and
territories. Except as specifically set forth therein, Alvotech
disclaims responsibility for the content of periodic filings,
disclosures and other reports made available by its partners. For
more information, please visit www.alvotech.com. None of the
information on the Alvotech website shall be deemed part of this
press release.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
global pharmaceutical leader with a category-defying portfolio,
harnessing our generics expertise and stepping up innovation to
continue the momentum behind the discovery, delivery, and expanded
development of modern medicine. For over 120 years, Teva's
commitment to bettering health has never wavered. Today, the
company’s global network of capabilities enables its 37,000
employees across 58 markets to push the boundaries of scientific
innovation and deliver quality medicines to help improve health
outcomes of millions of patients every day. To learn more about how
Teva is all in for better health, visit www.tevapharm.com.
INDICATIONS FOR SIMLANDI (adalimumab-ryvk) injection
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated
for:
- Rheumatoid Arthritis (RA): Reducing signs and symptoms,
inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult
patients with moderately to severely active RA. SIMLANDI can be
used alone or in combination with methotrexate or other nonbiologic
disease-modifying anti-rheumatic drugs (DMARDs).
- Juvenile Idiopathic Arthritis (JIA): Reducing signs and
symptoms of moderately to severely active polyarticular JIA in
patients 2 years of age and older. SIMLANDI can be used alone or in
combination with methotrexate.
- Psoriatic Arthritis (PsA): Reducing signs and symptoms,
inhibiting the progression of structural damage, and improving
physical function in adult patients with active PsA. SIMLANDI can
be used alone or in combination with non-biologic DMARDs.
- Ankylosing Spondylitis (AS): Reducing signs and symptoms
in adult patients with active AS.
- Crohn’s Disease (CD): Treatment of moderately to
severely active Crohn’s disease in adults and pediatric patients 6
years of age and older.
- Ulcerative Colitis (UC): Treatment of moderately to
severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been
established in patients who have lost response to or were
intolerant to TNF blockers.
- Plaque Psoriasis (Ps): Treatment of adult patients with
moderate to severe chronic plaque psoriasis who are candidates for
systemic therapy or phototherapy, and when other systemic therapies
are medically less appropriate.
- Hidradenitis Suppurativa (HS): Treatment of moderate to
severe hidradenitis suppurativa in adult patients (1.8)
- Uveitis (UV): Treatment of non-infectious intermediate,
posterior, and panuveitis in adult patients (1.9)
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS INFECTIONS and MALIGNANCY
SERIOUS INFECTIONS
Patients treated with adalimumab products, including
SIMLANDI, 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.
Discontinue SIMLANDI if a patient develops a serious
infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent
TB. Patients with TB have frequently presented with pulmonary or
extrapulmonary disease. Evaluate patients for tuberculosis risk
factors and test for latent TB before initiating SIMLANDI and
periodically during therapy. Initiate treatment for latent TB prior
to SIMLANDI use.
- Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other invasive
fungal infections may present with disseminated, rather than
localized, disease. Antigen and antibody testing for histoplasmosis
may be negative in some patients with active infection. Consider
empiric anti-fungal therapy in patients at risk for invasive fungal
infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic
pathogens, including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with
SIMLANDI prior to initiating therapy in patients: 1. with chronic
or recurrent infection, 2. who have been exposed to TB, 3. with a
history of opportunistic infection, 4. who resided in or traveled
in regions where mycoses are endemic, 5. with underlying conditions
that may predispose them to infection. Monitor patients closely for
the development of signs and symptoms of infection during and after
treatment with SIMLANDI, including the possible development of TB
in patients who tested negative for latent TB infection prior to
initiating therapy.
- Do not start SIMLANDI during an active infection, including
localized infections
- Patients 65 years of age and older, patients with co-morbid
conditions and/or patients taking concomitant immunosuppressants,
may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate
appropriate therapy.
- Drug interactions with biologic products: A higher rate of
serious infections has been observed in RA patients treated with
rituximab who received subsequent treatment with a TNF blocker. An
increased risk of serious infections has been seen with the
combination of TNF blockers with anakinra or abatacept, with no
demonstrated added benefit in patients with RA. Concomitant
administration of SIMLANDI with other biologic DMARDs (e.g.,
anakinra or abatacept) or other TNF blockers is not recommended
based on the possible increased risk for infections and other
potential pharmacological interactions.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been
reported in children and adolescent patients treated with TNF
blockers including adalimumab products. Postmarketing cases of
hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell
lymphoma, have been reported in patients treated with TNF blockers
including adalimumab products. These cases have had a very
aggressive disease course and have been fatal. The majority of
reported TNF blocker cases have occurred in patients with Crohn's
disease or ulcerative colitis and the majority were in adolescent
and young adult males. Almost all these patients had received
treatment with azathioprine or 6-mercaptopurine (6-MP)
concomitantly with a TNF blocker at or prior to diagnosis. It is
uncertain whether the occurrence of HSTCL is related to use of a
TNF blocker or a TNF blocker in combination with these other
immunosuppressants.
- Consider the risks and benefits of TNF blocker-treatment,
including SIMLANDI, prior to initiating therapy in patients with
known malignancy.
- Non-melanoma skin cancer (NMSC) was reported during clinical
trials for adalimumab-treated patients. Examine all patients,
particularly those with a history of prolonged immunosuppressant or
PUVA therapy for the presence of NMSC prior to and during treatment
with SIMLANDI.
- In the adalimumab clinical trials there was an approximate
3-fold higher rate of lymphoma than expected in the general U.S.
population. Patients with chronic inflammatory diseases,
particularly those with highly active disease and/or chronic
exposure to immunosuppressant therapies, may be at a higher risk
than the general population for the development of lymphoma, even
in the absence of TNF blockers.
- Postmarketing cases of acute and chronic leukemia have been
reported in association with TNF blocker use. Approximately half of
the postmarketing cases of malignancies in children, adolescents,
and young adults receiving TNF blockers were lymphomas; other cases
represented a variety of different malignancies and included rare
malignancies associated with immunosuppression and malignancies
that are not usually observed in children and adolescents.
Hypersensitivity Reactions
Anaphylaxis or serious allergic reactions have been reported
following administration of adalimumab products. If an anaphylactic
or other serious hypersensitivity reaction occurs, immediately
discontinue administration of SIMLANDI and institute appropriate
therapy.
Hepatitis B Virus Reactivation
- Use of TNF blockers, including SIMLANDI, may increase the risk
of reactivation of hepatitis B virus (HBV) in patients who are
chronic carriers. Some cases with HBV reactivation occurring in
conjunction with TNF blocker therapy have been fatal.
- Evaluate patients at risk for HBV infection for prior evidence
of HBV infection before initiating TNF blocker therapy.
- Exercise caution in patients identified as carriers of HBV and
closely monitor during and after SIMLANDI treatment.
- In patients who develop HBV reactivation, stop SIMLANDI and
initiate effective anti-viral therapy. Exercise caution when
resuming SIMLANDI after HBV treatment.
Neurologic Reactions
- Use of TNF blocking agents, including adalimumab products, have
been associated with rare cases of new onset or exacerbation of
central nervous system and peripheral demyelinating disease,
including multiple sclerosis, optic neuritis, and Guillain-Barré
syndrome.
- Exercise caution when considering SIMLANDI for patients with
these disorders; discontinuation of SIMLANDI should be considered
if any of these disorders develop.
- There is a known association between intermediate uveitis and
central demyelinating disorders.
Hematological Reactions
- Rare reports of pancytopenia, including aplastic anemia, have
been reported with TNF blocking agents. Medically significant
cytopenia has been infrequently reported with adalimumab
products.
- Advise patients to seek medical attention if they develop signs
and symptoms suggestive of blood dyscrasias or infection (e.g.,
persistent fever, bruising, bleeding, pallor).
- Consider stopping SIMLANDI if significant hematologic
abnormalities occur.
Heart Failure
Worsening and new onset congestive heart failure (CHF) have been
reported with TNF blockers. Cases of worsening CHF have also been
observed with adalimumab products; exercise caution when using
SIMLANDI in patients who have heart failure and monitor them
carefully.
Autoimmunity
Treatment with adalimumab products may result in the formation
of autoantibodies and, rarely, in the development of a lupus-like
syndrome. Discontinue treatment if symptoms of a lupus-like
syndrome develop.
Immunizations
- Patients on SIMLANDI should not receive live vaccines.
- Pediatric patients, if possible, should be brought up to date
with all immunizations prior to initiating SIMLANDI therapy.
- Adalimumab is actively transferred across the placenta during
the third trimester of pregnancy and may affect immune response in
the in utero exposed infant. The safety of administering live or
live-attenuated vaccines in infants exposed to adalimumab products
in utero is unknown. Risks and benefits should be considered prior
to vaccinating (live or live-attenuated) exposed infants.
ADVERSE REACTIONS
The most common adverse reactions (greater than or equal to
10%): are infections (e.g., upper respiratory, sinusitis),
injection site reactions, headache, and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Teva
Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Please click here for full Prescribing Information for
SIMLANDI, including BOXED WARNINGS and Medication Guide.
ALVOTECH Forward Looking Statements
Certain statements in this communication may be considered
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements generally relate to future events or the
future financial operating performance of Alvotech and may include,
for example, Alvotech’s expectations regarding competitive
advantages, business prospects and opportunities including pipeline
product development, future plans and intentions, results, level of
activities, performance, goals or achievements or other future
events, regulatory submissions, review and interactions, the
potential approval and commercial launch of its product candidates,
the timing of regulatory approval, and market launches. In some
cases, you can identify forward-looking statements by terminology
such as “may”, “should”, “expect”, “intend”, “will”, “estimate”,
“anticipate”, “believe”, “predict”, “potential”, “aim” or
“continue”, or the negatives of these terms or variations of them
or similar terminology. Such forward-looking statements are subject
to risks, uncertainties, and other factors which could cause actual
results to differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon estimates and assumptions that, while considered
reasonable by Alvotech and its management, are inherently uncertain
and are inherently subject to risks, variability, and
contingencies, many of which are beyond Alvotech’s control. Factors
that may cause actual results to differ materially from current
expectations include, but are not limited to: (1) the outcome of
any legal proceedings that may be instituted against Alvotech or
others following the business combination between Alvotech Holdings
S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to
raise substantial additional funding, which may not be available on
acceptable terms or at all; (3) the ability to maintain stock
exchange listing standards; (4) changes in applicable laws or
regulations; (5) the possibility that Alvotech may be adversely
affected by other economic, business, and/or competitive factors;
(6) Alvotech’s estimates of expenses and profitability; (7)
Alvotech’s ability to develop, manufacture and commercialize the
products and product candidates in its pipeline; (8) actions of
regulatory authorities, which may affect the initiation, timing and
progress of clinical studies or future regulatory approvals or
marketing authorizations; (9) the ability of Alvotech or its
partners to respond to inspection findings and resolve deficiencies
to the satisfaction of the regulators; (10) the ability of Alvotech
or its partners to enroll and retain patients in clinical studies;
(11) the ability of Alvotech or its partners to gain approval from
regulators for planned clinical studies, study plans or sites; (12)
the ability of Alvotech’s partners to conduct, supervise and
monitor existing and potential future clinical studies, which may
impact development timelines and plans; (13) Alvotech’s ability to
obtain and maintain regulatory approval or authorizations of its
products, including the timing or likelihood of expansion into
additional markets or geographies; (14) the success of Alvotech’s
current and future collaborations, joint ventures, partnerships or
licensing arrangements; (15) Alvotech’s ability, and that of its
commercial partners, to execute their commercialization strategy
for approved products; (16) Alvotech’s ability to manufacture
sufficient commercial supply of its approved products; (17) the
outcome of ongoing and future litigation regarding Alvotech’s
products and product candidates; (18) the impact of worsening
macroeconomic conditions, including rising inflation and interest
rates and general market conditions, war in Ukraine and global
geopolitical tension, on the Company’s business, financial
position, strategy and anticipated milestones; and (19) other risks
and uncertainties set forth in the sections entitled “Risk Factors”
and “Cautionary Note Regarding Forward-Looking Statements” in
documents that Alvotech may from time to time file or furnish with
the SEC. There may be additional risks that Alvotech does not
presently know or that Alvotech currently believes are immaterial
that could also cause actual results to differ from those contained
in the forward-looking statements. Nothing in this communication
should be regarded as a representation by any person that the
forward-looking statements set forth herein will be achieved or
that any of the contemplated results of such forward-looking
statements will be achieved. You should not place undue reliance on
forward-looking statements, which speak only as of the date they
are made. Alvotech does not undertake any duty to update these
forward-looking statements or to inform the recipient of any
matters of which any of them becomes aware of which may affect any
matter referred to in this communication. Alvotech disclaims any
and all liability for any loss or damage (whether foreseeable or
not) suffered or incurred by any person or entity as a result of
anything contained or omitted from this communication and such
liability is expressly disclaimed. The recipient agrees that it
shall not seek to sue or otherwise hold Alvotech or any of its
directors, officers, employees, affiliates, agents, advisors, or
representatives liable in any respect for the provision of this
communication, the information contained in this communication, or
the omission of any information from this communication.
TEVA Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to: our strategic partnership
with Alvotech; our ability to successfully commercialize SIMLANDI
in the U.S.; our ability to commercialize the additional biosimilar
product candidates under the strategic partnership with Alvotech
once U.S. regulatory approval is obtained; our ability to
successfully compete in the marketplace; our ability to develop and
commercialize additional pharmaceutical products; our ability to
successfully launch and execute our new Pivot to Growth strategy,
including to expand our innovative and biosimilar medicines
pipeline and profitably commercialize the innovative medicines and
biosimilar portfolio, whether organically or through business
development, and to sustain and focus our portfolio of generics
medicines; our business and operations in general, including: the
impact of global economic conditions and other macroeconomic
developments and the governmental and societal responses thereto;
our substantial indebtedness, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make
new investments; compliance, regulatory and litigation matters;
other financial and economic risks; and other factors discussed in
this press release, and in our Annual Report on Form 10-K for the
year ended December 31, 2023, including in the sections captioned
"Risk Factors” and “Forward Looking Statements.” Forward-looking
statements speak only as of the date on which they are made, and we
assume no obligation to update or revise any forward-looking
statements or other information contained herein, whether as a
result of new information, future events or otherwise. You are
cautioned not to put undue reliance on these forward-looking
statements.
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CONTACTS FOR THE MEDIA AND IR
ALVOTECH Investor Relations and Global Communications
Benedikt Stefansson, Senior Director alvotech.ir@alvotech.com
TEVA IR Contacts Ran Meir +1 (267) 468-4475 Yael
Ashman +972 (3) 914 8262 Sanjeev Sharma +1 (973) 658 2700
PR Contacts Kelley Dougherty +1 (973) 832-2810 Yonatan
Beker +1 (973) 264-7378 Yonatan.Beker@tevapharm.com Eden Klein +972
(3) 906 2645
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