- Adalimumab-aaty will be priced at an 85% discount to
HUMIRA® (adalimumab)
- Branded and unbranded versions of Celltrion USA's adalimumab biosimilar help provide more
affordable options for patients
JERSEY
CITY, N.J., May 9, 2024
/PRNewswire/ -- Celltrion USA
announced today that adalimumab-aaty, the company's
high-concentration (100 mg/mL) and citrate-free formulation
biosimilar to HUMIRA ® (adalimumab), is now
available at a low wholesale acquisition cost (WAC).
Adalimumab-aaty will be priced as WAC list price at an 85% discount
to the current WAC list price of HUMIRA. Adalimumab-aaty is also
available from Celltrion USA under
the brand name YUFLYMA®, which launched in
July 2023 and is available at a 5%
discount to the current WAC list price of HUMIRA.
Adalimumab-aaty is approved for the treatment of eight
conditions, including rheumatoid arthritis, juvenile idiopathic
arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's
disease, ulcerative colitis, plaque psoriasis, and hidradenitis
suppurativa.
"Access to medications in the U.S. has become increasingly
complex, and there is so much value that biosimilars add with
competition in the marketplace," said Thomas Nusbickel, Chief Commercial Officer at
Celltrion USA. "The availability
of branded and unbranded versions of adalimumab-aaty will improve
the accessibility of adalimumab biosimilars in the U.S., providing
economic benefits for patients and the overall healthcare
system."
Adalimumab-aaty is available as 40 mg/0.4mL, 80 mg/0.8mL and 20
mg/0.2mL.
IMPORTANT SAFETY INFORMATION[1]
This important safety
information also applies to
YUFLYMA® (adalimumab-aaty)
SERIOUS INFECTIONS
Patients treated with adalimumab-aaty 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 adalimumab-aaty 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
adalimumab-aaty use and during therapy. Initiate treatment for
latent TB prior to adalimumab-aaty 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 antifungal 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
adalimumab-aaty prior to initiating therapy in patients with
chronic or recurrent infection.
Monitor patients closely for the development of signs and
symptoms of infection during and after treatment with
adalimumab-aaty, including the possible development of TB in
patients who tested negative for latent TB infection prior to
initiating therapy.
- Treatment with adalimumab-aaty should not be initiated in
patients with an active infection, including localized
infections.
- Patients over 65 years of age, patients with co-morbid
conditions and/or patients taking concomitant immunosuppressants
(such as corticosteroids or methotrexate), may be at greater risk
of infection. Discontinue adalimumab-aaty if a patient develops a
serious infection or sepsis. For a patient who develops a new
infection during treatment with adalimumab-aaty, closely monitor
them, perform a prompt and complete diagnostic workup appropriate
for an immunocompromised patient, and initiate appropriate
antimicrobial therapy.
- Drug interactions with biologic products: In clinical studies
in patients with RA, an increased risk of serious infections has
been observed with the combination of TNF blockers with anakinra or
abatacept, with no added benefit; therefore, use of adalimumab-aaty
with abatacept or anakinra is not recommended in patients with RA.
A higher rate of serious infections has also been observed in
patients with RA treated with rituximab who received subsequent
treatment with a TNF blocker. There is insufficient information
regarding the concomitant use of adalimumab-aaty and other biologic
products for the treatment of RA, PsA, AS, CD, UC, PS, and HS.
Concomitant administration of adalimumab-aaty with other biologic
DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not
recommended based upon the possible increased risk for infections
and other potential pharmacological interactions. A higher rate of
serious infections has been observed in RA patients treated with
rituximab who received subsequent treatment with a TNF
blocker.
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 the 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 adalimumab-aaty prior to initiating therapy in patients
with a known malignancy other than a successfully treated
non-melanoma skin cancer (NMSC), or when considering continuing a
TNF blocker in patients who develop a malignancy.
- In controlled portions of clinical trials of some adalimumab
products, more cases of malignancies have been observed compared to
control-treated adult patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical
trials for patients treated with adalimumab products. During the
controlled portions of 39 global adalimumab clinical trials in
adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95%
confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100
patient-years among adalimumab-treated patients and 0.2 (0.10,
0.59) per 100 patient-years among control-treated patients. Examine
all patients, particularly those with a medical history of prior
prolonged immunosuppressant therapy or psoriasis patients with a
history of PUVA treatment, for the presence of NMSC prior to and
during treatment with adalimumab-aaty.
- In clinical trials of some adalimumab products, there was an
approximately threefold higher rate of lymphoma than expected in
the general U.S. population. Patients with RA and other chronic
inflammatory diseases, particularly those with highly active
disease and/or chronic exposure to immunosuppressant therapies, may
be at a higher risk (up to severalfold) than the general population
for the development of lymphoma, even in the absence of TNF
blockers.
- Postmarketing cases of acute and chronic leukemia were reported
with the use of a TNF blocker in RA and other indications.
Approximately half of the postmarketing cases of malignancies in
children, adolescents, and young adults receiving adalimumab were
lymphomas; other cases represented a variety of different
malignancies and included rare malignancies usually associated with
immunosuppression and malignancies that are not usually observed in
children and adolescents.
HYPERSENSITIVITY
- Anaphylaxis and angioneurotic edema have been reported
following administration of adalimumab products. If an anaphylactic
or other serious allergic reaction occurs, immediately discontinue
administration of adalimumab-aaty and institute appropriate
therapy.
HEPATITIS B VIRUS REACTIVATION
- Use of TNF blockers, including adalimumab-aaty, may increase
the risk of reactivation of hepatitis B virus (HBV) in patients who
are chronic carriers. In some instances, HBV reactivation occurring
in conjunction with TNF blocker therapy has been fatal.
- Evaluate patients at risk for HBV infection for prior evidence
of HBV infection before initiating TNF blocker therapy.
- Exercise caution in prescribing TNF blockers for patients
identified as carriers of HBV and closely monitor such patients for
clinical and laboratory signs of active HBV infection throughout
therapy and for several months following termination of
therapy.
- In patients who develop HBV reactivation, stop adalimumab-aaty
and initiate effective antiviral therapy with appropriate
supportive treatment. The safety of resuming TNF blocker therapy
after HBV reactivation is controlled is not known. Therefore,
exercise caution when considering resumption of adalimumab-aaty
therapy in this situation and monitor patients closely.
NEUROLOGIC REACTIONS
- Use of TNF blocking agents, including adalimumab products, has
been associated with rare cases of new onset or exacerbation of
clinical symptoms and/or radiographic evidence of central nervous
system demyelinating disease, including multiple sclerosis (MS) and
optic neuritis, and peripheral demyelinating disease, including
Guillain-Barré syndrome.
- Exercise caution in considering the use of adalimumab-aaty in
patients with preexisting or recent-onset central or peripheral
nervous system demyelinating disorders; discontinuation of
adalimumab-aaty should be considered if any of these disorders
develop.
- There is a known association between intermediate uveitis and
central demyelinating disorders.
HEMATOLOGIC REACTIONS
- Rare reports of pancytopenia including aplastic anemia have
been reported with TNF blocking agents.
- Adverse reactions of the hematologic system, including
medically significant cytopenia, have been infrequently reported
with adalimumab products.
- Consider discontinuation of adalimumab-aaty therapy in patients
with confirmed significant hematologic abnormalities.
HEART FAILURE
- Cases of worsening congestive heart failure (CHF) and new-onset
CHF have been reported with TNF blockers. Cases of worsening CHF
have also been observed with adalimumab products.
- Exercise caution when using adalimumab-aaty 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. If a patient develops symptoms suggestive of a lupus-like
syndrome following treatment with adalimumab-aaty, discontinue
treatment.
IMMUNIZATIONS
- Patients on adalimumab-aaty may receive concurrent
vaccinations, except for live vaccines.
- It is recommended that pediatric patients, if possible, be
brought up to date with all immunizations in agreement with current
immunization guidelines prior to initiating adalimumab-aaty
therapy.
- No data are available on the secondary transmission of
infection by live vaccines in patients receiving adalimumab
products.
- The safety of administering live or live-attenuated vaccines in
infants exposed to adalimumab 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.
INDICATIONS
Adalimumab-aaty 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
- Juvenile Idiopathic Arthritis (JIA): reducing signs and
symptoms of moderately to severely active polyarticular JIA in
patients 2 years of age and older
- Psoriatic Arthritis (PsA): reducing signs and symptoms,
inhibiting the progression of structural damage, and improving
physical function in adult patients with active PsA
- 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 adults
- 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 adult patients with
moderate to severe hidradenitis suppurativa
Please see full Prescribing Information including Boxed
Warning for adalimumab-aaty
About adalimumab-aaty[1]
Adalimumab-aaty is an unbranded version of
YUFLYMA® (CT-P17, biosimilar adalimumab).
YUFLYMA is a recombinant fully human anti–tumour
necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is
FDA-approved for the treatment of patients with rheumatoid
arthritis, juvenile idiopathic arthritis, psoriatic arthritis,
ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque
psoriasis and Hidradenitis Suppurativa. Following the launch of
40mg/0.4mL in July 2023 and
80mg/0.8mL in December 2023,
additional dosage form of 20mg/0.2mL was launched in the U.S. in
March 2024.
About Celltrion USA
Celltrion USA is Celltrion's
U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to
innovative biologics to improve care for U.S. patients. Celltrion
currently has five biosimilars approved by the U.S. FDA:
INFLECTRA® (infliximab-dyyb),
TRUXIMA® (rituximab-abbs),
HERZUMA® (trastuzumab-pkrb),
VEGZELMA® (bevacizumab-adcd) and
YUFLYMA®(adalimumab-aaty) as well as a new biologic
ZYMFENTRA™. Celltrion USA will
continue to leverage Celltrion's unique heritage in biotechnology,
supply chain excellence and best-in-class sales capabilities to
improve access to high-quality biopharmaceuticals for U.S.
patients. For more information, please visit:
www.celltrionusa.com/
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains
statements related to our future business and financial performance
and future events or developments involving Celltrion that may
constitute forward-looking statements, under pertinent securities
laws.
These statements may be identified by words such as "prepares,"
"hopes to," "upcoming," "plans to," "aims to," "to be launched,"
"is preparing," "once gained," "could," "with the aim of," "may,"
"once identified," "will," "working towards," "is due," "become
available," "has potential to," the negative of these words or such
other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking
statements. Such statements are based on the current expectations
and certain assumptions of Celltrion's management, of which many
are beyond its control.
Forward-looking statements are provided to allow potential
investors the opportunity to understand management's beliefs and
opinions with respect to the future so that they may use such
beliefs and opinions as one factor in evaluating an investment.
These statements are not guarantees of future performance and undue
reliance should not be placed on them.
Such forward-looking statements necessarily involve known and
unknown risks and uncertainties, which may cause actual performance
and financial results in future periods to differ materially from
any projections of future performance or results expressed or
implied by such forward-looking statements.
Such Risks and uncertainties may include, among other things,
uncertainties regarding the launch timing and commercial success of
Celltrion in the United States;
the uncertainties inherent in supply chain, manufacturing, research
and development, and the possibility of unfavorable new clinical
data and further analyses of existing clinical data as it relates
to Celltrion products; intellectual property and/or
litigation/settlement implications; decisions by the FDA impacting
labeling, manufacturing processes, safety, promotion, and/or other
matters that could affect the availability or commercial potential
of Celltrion products; and uncertainties regarding access
challenges for our biosimilar products where our product may not
receive appropriate formulary access or remains in a disadvantaged
position relative to competitive products; and competitive
developments. A further description of risks and uncertainties can
be found in Celltrion's Annual Report.
Although forward-looking statements contained in this
presentation are based upon what management of Celltrion believes
are reasonable assumptions, there can be no assurance that
forward-looking statements will prove to be accurate, as actual
results and future events could differ materially from those
anticipated in such statements. Celltrion undertakes no obligation
to update forward-looking statements if circumstances or
management's estimates or opinions should change except as required
by applicable securities laws. The reader is cautioned not to place
undue reliance on forward-looking statements.
Trademarks
HUMIRA® is a
registered trademark of AbbVie Biotechnology Ltd.
YUFLYMA® is a registered trademark of Celltrion,
Inc., used under license.
References
[1] Adalimumab-aaty
U.S. prescribing information
|
US-YUF-24-00007 04/24
Contacts
Sarah
Amundsen
samundsen@apcoworldwide.com
+1 920-946-0918
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SOURCE Celltrion USA