THOUSAND OAKS, Calif.,
March 23, 2017 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the European
Commission (EC) has granted marketing authorization for AMGEVITA™
(biosimilar adalimumab1) in all available indications.
AMGEVITA is authorized for the treatment of certain inflammatory
diseases in adults, including moderate-to-severe rheumatoid
arthritis; psoriatic arthritis; severe active ankylosing
spondylitis (AS); severe axial spondyloarthritis without
radiographic evidence of AS; moderate-to-severe chronic plaque
psoriasis; moderate-to-severe hidradenitis suppurativa;
non-infectious intermediate, posterior and panuveitis;
moderate-to-severe Crohn's disease and moderate-to-severe
ulcerative colitis. The EC also approved AMGEVITA for the treatment
of certain pediatric inflammatory diseases, including
moderate-to-severe Crohn's disease (ages six and older), severe
chronic plaque psoriasis (ages four and older), enthesitis-related
arthritis (ages six and older) and polyarticular juvenile
idiopathic arthritis (ages two and older).
"The approval of our first biosimilar by the European Commission
is a major milestone not just for Amgen as a company, but for the
millions of patients with chronic inflammatory diseases who need
alternative treatment options," said Sean
E. Harper, M.D., executive vice president of Research and
Development at Amgen. "In addition, AMGEVITA holds the potential to
offer patients with chronic inflammatory diseases an additional
treatment option. This milestone exemplifies our ongoing dedication
to the development of high-quality biologic medicines."
The EC approved AMGEVITA based on a comprehensive data package
supporting biosimilarity to adalimumab based on analytical,
pharmacokinetic and clinical data, including results from two Phase
3 studies conducted in moderate-to-severe plaque psoriasis and
moderate-to-severe rheumatoid arthritis patients. The Phase 3
studies each met their primary endpoint showing no clinically
meaningful differences to adalimumab. Safety and immunogenicity of
AMGEVITA were also comparable to adalimumab.
Approval from the EC grants a centralized marketing
authorization with unified labeling in the 28 countries that are
members of the EU. Norway,
Iceland and Liechtenstein, as members of the European
Economic Area (EEA), will take corresponding decisions on the basis
of the decision of the EC.
AMGEVITA was approved in the United
States (U.S.) by the U.S. Food and Drug Administration on
Sept. 23, 2016. In the U.S., the
brand name is AMJEVITA™ (adalimumab-atto).
About AMGEVITA™ (biosimilar adalimumab) in the
EU
AMGEVITA is a biosimilar to adalimumab, an anti-TNF-α
monoclonal antibody. The active ingredient of AMGEVITA is an
anti-TNF-α monoclonal antibody that has the same amino acid
sequence as, and is highly similar to, adalimumab. AMGEVITA will be
delivered in prefilled syringe and autoinjector presentations to
support dosing according to the approved dosage recommendations in
each indication.
AMGEVITA, in combination with methotrexate, is indicated
for:
- the treatment of moderate-to-severe, active rheumatoid
arthritis in adult patients when the response to disease-modifying
anti-rheumatic drugs including methotrexate has been
inadequate.
- the treatment of severe, active and progressive rheumatoid
arthritis in adults not previously treated with methotrexate.
AMGEVITA can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment with methotrexate is
inappropriate. AMGEVITA reduces the rate of progression of joint
damage as measured by X-ray and improves physical function, when
given in combination with methotrexate.
AMGEVITA, in combination with methotrexate, is indicated for the
treatment of active polyarticular juvenile idiopathic arthritis, in
patients from the age of two years who have had an inadequate
response to one or more disease-modifying anti-rheumatic drugs
(DMARDs). AMGEVITA can be given as monotherapy in case of
intolerance to methotrexate or when continued treatment with
methotrexate is inappropriate. Adalimumab has not been studied in
patients aged less than two years.
AMGEVITA is indicated for the treatment of active
enthesitis-related arthritis in patients, six years of age and
older, who have had an inadequate response to, or who are
intolerant of, conventional therapy.
AMGEVITA is indicated for the treatment of adults with severe
active ankylosing spondylitis who have had an inadequate response
to conventional therapy.
AMGEVITA is indicated for the treatment of adults with severe
axial spondyloarthritis without radiographic evidence of AS but
with objective signs of inflammation by elevated CRP and/or MRI,
who have had an inadequate response to, or are intolerant to
non-steroidal anti-inflammatory drugs.
AMGEVITA is indicated for the treatment of active and
progressive psoriatic arthritis in adults when the response to
previous disease-modifying anti-rheumatic drug therapy has been
inadequate. AMGEVITA reduces the rate of progression of peripheral
joint damage as measured by X-ray in patients with polyarticular
symmetrical subtypes of the disease and improves physical
function.
AMGEVITA is indicated for the treatment of moderate-to-severe
chronic plaque psoriasis in adult patients who are candidates for
systemic therapy.
AMGEVITA is indicated for the treatment of severe chronic plaque
psoriasis in children and adolescents from four years of age who
have had an inadequate response to or are inappropriate candidates
for topical therapy and phototherapies.
AMGEVITA is indicated for the treatment of active
moderate-to-severe hidradenitis suppurativa (HS) (acne inversa) in
adult patients with an inadequate response to conventional systemic
HS therapy.
AMGEVITA is indicated for the treatment of moderately to
severely active Crohn's disease, in adult patients who have not
responded despite a full and adequate course of therapy with a
corticosteroid and/or an immunosuppressant; or who are intolerant
to or have medical contraindications for such therapies.
AMGEVITA is indicated for the treatment of moderately to
severely active Crohn's disease in pediatric patients (from six
years of age) who have had an inadequate response to conventional
therapy including primary nutrition therapy, a corticosteroid, and
an immunomodulator, or who are intolerant to or have
contraindications for such therapies.
AMGEVITA is indicated for the treatment of moderately to
severely active ulcerative colitis in adult patients who have had
an inadequate response to conventional therapy including
corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA),
or who are intolerant to or have medical contraindications for such
therapies.
AMGEVITA is indicated for the treatment of non-infectious
intermediate, posterior and panuveitis in adult patients who have
had an inadequate response to corticosteroids, in patients in need
of corticosteroid-sparing, or in whom corticosteroid treatment is
inappropriate.
AMGEVITA™ EU Important Safety Information
This
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse
reactions.
AMGEVITA treatment should be initiated and supervised by
specialist physicians experienced in the diagnosis and treatment of
conditions for which AMGEVITA is indicated. The most serious side
effects that may occur during AMGEVITA treatment include infections
such as sepsis or other opportunistic infections, tuberculosis
(TB), hepatitis B reactivation (HBV) and other malignancies
including leukemia, lymphoma and hepatosplenic T-cell lymphoma
(HSTCL). Other rare serious haematological, neurological and
autoimmune reactions that may occur during AMGEVITA treatment
include pancytopenia, aplastic anaemia, central and peripheral
demyelinating events, lupus, lupus-related conditions and
Stevens-Johnson syndrome. The most common side effects are
infections in the nose and throat, sinuses and upper respiratory
tract, injection site reactions (redness, itching, bleeding, pain
or swelling), headache and muscle and bone pain.
AMGEVITA is contraindicated in people with sensitivities to
certain excipients (e.g., glacial acetic acid, sucrose, polysorbate
80, sodium hydroxide (for pH adjustment) and water for injections);
in people with active tuberculosis or other severe infections
(e.g., sepsis), and those with moderate to severe heart failure
(NYHA class III/IV). Patients on AMGEVITA may receive concurrent
vaccinations, except for live vaccines.
Please refer to the Summary of Product Characteristics for full
European prescribing information.
About AMJEVITA™ (adalimumab-atto) in the
U.S.
AMJEVITA is a biosimilar to 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, and has been determined by FDA to be highly similar
to, adalimumab. AMJEVITA will be delivered in prefilled syringe and
autoinjector presentations to support dosing in each of the
approved indications.
AMJEVITA is indicated, alone or in combination with methotrexate
or other non-biologic DMARDs, 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.
AMJEVITA is indicated, alone or in combination with
methotrexate, for reducing signs and symptoms of moderately to
severely active polyarticular juvenile idiopathic arthritis in
patients 4 years of age and older.
AMJEVITA is indicated, alone or in combination with non-biologic
DMARDs, for reducing signs and symptoms, inhibiting the progression
of structural damage, and improving physical function in adult
patients with active psoriatic arthritis.
AMJEVITA is indicated for reducing signs and symptoms in adult
patients with active ankylosing spondylitis.
AMJEVITA is indicated for reducing signs and symptoms and
inducing and maintaining clinical remission in adult patients with
moderately to severely active Crohn's disease who have had an
inadequate response to conventional therapy, and reducing signs and
symptoms and inducing clinical remission in these patients if they
have also lost response to or are intolerant to infliximab.
AMJEVITA is indicated for inducing and sustaining clinical
remission in adult patients with moderately to severely active
ulcerative colitis who have had an inadequate response to
immunosuppressants such as corticosteroids, azathioprine, or
6-mercaptopurine. The effectiveness of adalimumab products has not
been established in patients who have lost response to or were
intolerant to TNF blockers.
AMJEVITA is indicated for 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 is currently not available commercially. This is
not an offer for sale. The following information is derived
from the approved label in the U.S.
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
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.
Concurrent use of AMJEVITA with 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. Post-marketing 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 TNF-blocker treatment 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 and 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 full Prescribing Information,
including Medication Guide.
About Amgen Biosimilars
Amgen Biosimilars is committed
to building upon Amgen's experience in the development
and manufacturing of innovative human therapeutics to
expand Amgen's reach to patients with serious illnesses.
Biosimilars will help to maintain Amgen's commitment to
connect patients with vital medicines, and Amgen is well
positioned to leverage its more than 35 years of experience in
biotechnology to create high quality biosimilars and reliably
supply them to patients worldwide.
For more information,
visit www.amgenbiosimilars.com and follow us
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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
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For more information, visit www.amgen.com and follow us on
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CONTACT: Amgen, Thousand
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Emma Gilbert, +41 41 369 2542
1 Biosimilar adalimumab has also been approved in the
EU as SOLYMBIC under a duplicate marketing authorization.
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