Four Years of Real-World Experience in More
Than 300,000 Patients and Over 60 Countries1
THOUSAND
OAKS, Calif., Jan. 31,
2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced AMJEVITA™ (adalimumab-atto), a biosimilar to
Humira®* (adalimumab), is now available in
the United States. AMJEVITA was
the first biosimilar to Humira approved by the U.S. Food and Drug
Administration (FDA), in 2016.2,3
"With today's announcement, AMJEVITA is the first U.S.
biosimilar to Humira®, a medicine used by more than a
million patients living with certain serious inflammatory
diseases," said Murdo Gordon,
executive vice president of Global Commercial Operations at Amgen.
"With our track record of developing and manufacturing biologics
and decades of experience in inflammation, Amgen is uniquely
equipped to supply this biosimilar medicine while reducing
costs."
"Biosimilars are extensively studied, FDA-approved treatments
that have the potential to reduce costs to the healthcare system,"
said Steven Taylor, president and
chief executive officer at the Arthritis Foundation. "AMJEVITA
provides another treatment option for patients and their
doctors."
AMJEVITA (40 mg) is available at a list price (Wholesale
Acquisition Cost) 55% below the current Humira list price. AMJEVITA
is also available at a list price 5% below the current Humira list
price. Amgen's goal is to provide broad access for patients by
offering two options to health plans and pharmacy benefit managers.
More information on Amgen's approach to responsible pricing is on
the company's website.
Like Humira's citrate-free formulation that is associated with
less pain at the injection site, AMJEVITA is
citrate-free.2,4 AMJEVITA will be available in
prefilled syringe and autoinjector presentations to support dosing
in each of the approved indications. Amgen offers patient support,
such as financial support information and educational resources,
through AMJEVITA SupportPlus. To learn more, visit
AMJEVITA.com.
Amgen currently has 11 biosimilar medicines in market or under
development. Five are FDA-approved in the U.S. and three are
approved in the European Union.
About AMJEVITA™ (adalimumab-atto)
AMJEVITA is a
biosimilar to Humira®* (adalimumab), an anti-TNF-α
monoclonal antibody. The active ingredient of AMJEVITA is an
anti-TNF-α monoclonal antibody that has the same amino acid
sequence as Humira. AMJEVITA is approved to treat seven
inflammatory diseases including moderate-to-severe rheumatoid
arthritis in adults, moderate-to-severe polyarticular juvenile
idiopathic arthritis in patients 2 years of age and older,
psoriatic arthritis in adults, ankylosing spondylitis in adults,
moderate-to-severe chronic plaque psoriasis in adults,
moderate-to-severe Crohn's disease in adults and pediatric patients
6 years of age and older and moderate-to-severe ulcerative colitis
in adults.2 AMJEVITA outside the U.S. is marketed as
AMGEVITA® (adalimumab) and has been prescribed to more
than 300,000 patients in over 60 countries.
*Humira® is a registered trademark of AbbVie,
Inc.
In the U.S., AMJEVITA is indicated for:
- 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 rheumatoid arthritis, alone or in combination with
methotrexate or other non-biologic DMARDs.
- reducing signs and symptoms of moderately to severely active
polyarticular juvenile idiopathic arthritis in patients 2 years of
age and older, alone or in combination with methotrexate.
- reducing signs and symptoms, inhibiting the progression of
structural damage, and improving physical function in adult
patients with active psoriatic arthritis, alone or in combination
with non-biologic DMARDs.
- reducing signs and symptoms in adult patients with active
ankylosing spondylitis.
- the treatment of moderately to severely active Crohn's disease
in adults and pediatric patients 6 years of age and older.
- the treatment of moderately to severely active ulcerative
colitis in adult patients. The effectiveness of adalimumab products
has not been established in patients who have lost response to or
were intolerant to TNF blockers.
- the 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. AMJEVITA should only be administered to patients who
will be closely monitored and have regular follow-up visits with a
physician.
AMJEVITA™ U.S. Important Safety Information
SERIOUS INFECTIONS
Patients treated with AMJEVITA 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 AMJEVITA 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 disseminated or
extrapulmonary disease. Test patients for latent TB before AMJEVITA
use and during therapy. Initiate treatment for latent TB prior to
AMJEVITA 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
AMJEVITA 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 AMJEVITA, including the possible development of TB
in patients who tested negative for latent TB infection prior to
initiating therapy.
- Do not start AMJEVITA during an active infection, including
localized infections.
- Patients older than 65 years, 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 rheumatoid arthritis (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 AMJEVITA 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 of these patients had received
treatment with azathioprine or 6-mercaptopurine 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 AMJEVITA prior to initiating
or continuing therapy in a patient with known malignancy.
- In clinical trials of some TNF blockers, including adalimumab
products, more cases of malignancies were observed among
TNF-blocker-treated patients compared to control patients.
- 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 AMJEVITA.
- In 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 higher risk of
lymphoma than the general population, even in the absence of TNF
blockers.
- Postmarketing cases of acute and chronic leukemia were reported
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 included rare
malignancies associated with immunosuppression and malignancies not
usually observed in children and adolescents.
HYPERSENSITIVITY
Anaphylaxis and angioneurotic edema have been reported following
administration of adalimumab products. If a serious allergic
reaction occurs, stop AMJEVITA and institute appropriate
therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including AMJEVITA, may increase the risk
of reactivation of hepatitis B virus (HBV) in patients who are
chronic carriers. Some cases 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 who are carriers of HBV and monitor them during and
after AMJEVITA treatment. Discontinue AMJEVITA and begin antiviral
therapy in patients who develop HBV reactivation. Exercise caution
when resuming AMJEVITA after HBV treatment.
NEUROLOGIC REACTIONS
TNF blockers, including adalimumab products, have been
associated with rare cases of new onset or exacerbation of central
nervous system and peripheral demyelinating diseases, including
multiple sclerosis, optic neuritis, and Guillain-Barré
syndrome. Exercise caution when considering AMJEVITA for
patients with these disorders; discontinuation of AMJEVITA should
be considered if any of these disorders develop.
HEMATOLOGICAL REACTIONS
Rare reports of pancytopenia, including aplastic anemia, have
been reported with TNF blockers. Medically significant cytopenia
has been infrequently reported with adalimumab products.
Consider stopping AMJEVITA if significant hematologic abnormalities
occur.
CONGESTIVE HEART FAILURE
Worsening or new onset congestive heart failure (CHF) has been
reported with TNF blockers. Cases of worsening CHF have been
observed with adalimumab products; exercise caution and monitor
carefully.
AUTOIMMUNITY
Treatment with adalimumab products may result in the formation
of autoantibodies and, rarely, in development of a lupus-like
syndrome. Discontinue treatment if symptoms of a lupus-like
syndrome develop.
IMMUNIZATIONS
Patients on AMJEVITA should not receive live vaccines. Pediatric
patients, if possible, should be brought up to date with all
immunizations before initiating AMJEVITA 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 in adalimumab clinical trials
(>10%) were: infections (e.g., upper respiratory, sinusitis),
injection site reactions, headache, and rash.
Please see the accompanying AMJEVITA full Prescribing
Information, including Medication Guide.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
potential.
Amgen is one of the 30 companies that comprise the Dow
Jones Industrial Average and is also part of the Nasdaq-100 index.
In 2022, Amgen was named one of the "World's Best Employers" by
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Barron's.
For more information, visit Amgen.com and follow us
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References
- Data on File. Amgen. 2022.
- AMJEVITA U.S. prescribing information. Available at:
https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Amjevita/amjevita_pi_hcp_english.pdf
[Last accessed: January 2023]
- Food and Drug Administration. FDA approves Amjevita, a
biosimilar to Humira. Available at:
https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira.
Last accessed January 2023.
- Nash P, et al. Randomized Crossover Comparison of
Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of
Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol
Ther. 2016 Dec; 3 (2): 257-270.
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