Organon (NYSE: OGN), a global healthcare company with a
dedicated commitment to biosimilars, announced that the US
Department of Veterans Affairs (VA) has exclusively selected
HADLIMA in replacement of HUMIRA (adalimumab) for the VA National
Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the
treatment of specific autoimmune or autoinflammatory conditions
such as rheumatoid arthritis, Crohn’s disease, hidradenitis
suppurativa, and plaque psoriasis (see full indications below).
"America’s veterans deserve access to quality medicines at a
lower cost. We are proud to support the more than nine million
people enrolled in the VA healthcare system through this
collaboration, which is a great example of industry and public
sector working together,” said Kevin Ali, Organon CEO. “We applaud
the VA for its leadership in championing biosimilars and including
all three of Organon’s biosimilars available in the US on its
formulary."
HADLIMA was launched in the US to offer patients a more
affordable option without compromising on safety and efficacy.
HADLIMA is FDA approved in both citrate-free high concentration (40
mg/0.4 mL), the most-utilized formulation of the originator, and
citrate-containing low concentration (40 mg/0.8 mL) formulations to
provide patients with continuity of care. Intended to fit into a
patient’s lifestyle, HADLIMA is available in both a pre-filled
syringe and autoinjector option. The HADLIMATM PushTouch™
Autoinjector was specifically designed with the patient in mind,
with a thin 29G needle, a latex-free needle cover, and a buttonless
device with a sure-grip shape and a non-slip surface. The PushTouch
Autoinjector has been awarded the Arthritis Foundation’s Ease of
Use Certification, which recognizes products that make life easier
for those living with arthritis and other functional limitations
via lab and patient testing by the Intuitive Design Applied
Research Institute (IDARI).1
Patients treated with adalimumab products, including HADLIMA,
are at increased risk for developing serious infections that may
lead to hospitalization or death. Discontinue HADLIMA if a patient
develops a serious infection or sepsis. Monitor patients closely
for the development of signs and symptoms of infection during and
after treatment with HADLIMA, including the possible development of
tuberculosis (TB) in patients who tested negative for latent TB
infection prior to initiating therapy. Lymphoma and other
malignancies, some fatal, have been reported in children and
adolescent patients treated with TNF blockers including adalimumab
products. See additional safety information below.
About HADLIMA™ (adalimumab-bwwd) Injection, 40 mg/0.4 mL and
40 mg/0.8 mL
HADLIMA is a tumor necrosis factor (TNF) blocker indicated
for:
- Rheumatoid Arthritis: HADLIMA is indicated, alone or in
combination with methotrexate or other non-biologic
disease-modifying antirheumatic drugs (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.
- Juvenile Idiopathic Arthritis: HADLIMA is indicated,
alone or in combination with methotrexate, for reducing signs and
symptoms of moderately to severely active polyarticular juvenile
idiopathic arthritis in patients 2 years of age and older.
- Psoriatic Arthritis: HADLIMA 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.
- Ankylosing Spondylitis: HADLIMA is indicated for
reducing signs and symptoms in adult patients with active
ankylosing spondylitis.
- Crohn’s Disease: HADLIMA is indicated for the treatment
of moderately to severely active Crohn’s disease in adults and
pediatric patients 6 years of age and older.
- Ulcerative Colitis: HADLIMA is indicated for the
treatment of moderately to severely active ulcerative colitis in
adult patients. Limitations of Use:
The effectiveness of HADLIMA has not been established in patients
who have lost response to or were intolerant to tumor necrosis
factor (TNF) blockers.
- Plaque Psoriasis: HADLIMA 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. HADLIMA
should only be administered to patients who will be closely
monitored and have regular follow-up visits with a physician.
- Hidradenitis Suppurativa: HADLIMA is indicated for the
treatment of moderate to severe hidradenitis suppurativa in adult
patients.
- Uveitis: HADLIMA is indicated for the treatment of
non-infectious intermediate, posterior, and panuveitis in adult
patients.
SELECTED SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with adalimumab products, including HADLIMA,
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 HADLIMA 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 HADLIMA
use and during therapy. Initiate treatment for latent TB prior to
HADLIMA 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
HADLIMA prior to initiating therapy in patients:
- with chronic or recurrent infection
- who have been exposed to TB
- with a history of opportunistic infection
- who resided in or traveled in regions where mycoses are
endemic
- 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 HADLIMA,
including the possible development of TB in patients who tested
negative for latent TB infection prior to initiating
therapy.
- Do not start HADLIMA 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 HADLIMA with other biologic DMARDs
(eg, 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 HADLIMA treatment prior to
initiating or continuing therapy in a patient with known
malignancy.
- In clinical trials, more cases of malignancies were observed
among adalimumab-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
psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC
prior to and during treatment with HADLIMA.
- 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
adalimumab administration. If a serious allergic reaction occurs,
stop HADLIMA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including HADLIMA, 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 HADLIMA treatment.
Discontinue HADLIMA and begin antiviral therapy in patients who
develop HBV reactivation. Exercise caution when resuming HADLIMA
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 HADLIMA for patients with
these disorders; discontinuation of HADLIMA should be considered if
any of these disorders develop.
HEMATOLOGIC 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 HADLIMA 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 HADLIMA should not receive live vaccines.
Pediatric patients, if possible, should be brought up to date
with all immunizations before initiating HADLIMA 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 (eg, upper respiratory, sinusitis),
injection site reactions, headache, and rash.
Before prescribing HADLIMA, please read the accompanying
Prescribing Information, including the Boxed Warning
about serious infections and malignancies. The Medication
Guide and Instructions for Use also are
available.
About Organon
Organon is a global healthcare company formed to focus on
improving the health of women throughout their lives. Organon
offers more than 60 medicines and products in women’s health in
addition to a growing biosimilars business and a large franchise of
established medicines across a range of therapeutic areas.
Organon’s existing products produce strong cash flows that support
investments in innovation and future growth opportunities in
women’s health and biosimilars. In addition, Organon is pursuing
opportunities to collaborate with biopharmaceutical innovators
looking to commercialize their products by leveraging its scale and
presence in fast growing international markets.
Organon has a global footprint with significant scale and
geographic reach, world-class commercial capabilities, and
approximately 10,000 employees with headquarters located in Jersey
City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
Cautionary Note Regarding Forward-Looking Statements
Some statements and disclosures in this press release are
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about Organon’s
expectations regarding HADLIMA™ and its selection for inclusion in
the VA National Formulary for veterans. Forward-looking statements
include all statements that do not relate solely to historical or
current facts and can be identified by the use of words such as
"may," “expects,” “intends,” “anticipates,” “plans,” “believes,”
“seeks,” “estimates,” “will,” or words of similar meaning. These
forward-looking statements are based on Organon’s current plans and
expectations and are subject to a number of risks and uncertainties
that could cause Organon’s plans and expectations, including actual
results, to differ materially from the forward-looking
statements.
Risks and uncertainties that may affect Organon’s future results
include, but are not limited to, an inability to fully execute on
the product development and commercialization plans for HADLIMA in
the United States due to Organon’s inability to realize the
benefits of its SB5 HADLIMA biosimilar; any future discontinuation
of the inclusion of HADLIMA in the VA National Formulary for
veterans; efficacy, safety, or other quality concerns with respect
to marketed products, including market actions such as recalls,
withdrawals, or declining sales; political and social pressures, or
regulatory developments, that adversely impact demand for,
availability of, or patient access to Organon’s products; general
economic factors, including recessionary pressures, interest rate
and currency exchange rate fluctuations; general industry
conditions and competition; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances; new products and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approval; Organon’s ability to
accurately predict its future financial results and performance;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; difficulties developing
and sustaining relationships with commercial counterparties;
dependence on the effectiveness of Organon’s patents and other
protections for innovative products; the impact of the ongoing
COVID-19 pandemic and emergence of variant strains; and the
exposure to litigation, including patent litigation, and/or
regulatory actions.
Organon undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Organon’s filings with
the Securities and Exchange Commission ("SEC"), including Organon’s
most recent Annual Report on Form 10-K and subsequent SEC filings,
available at the SEC’s Internet site (www.sec.gov).
1 HADLIMA Prefilled syringe and autoinjector Ease of Use
Certification. Arthritis Foundation. July 1, 2023. Accessed
February 12, 2024.
https://www.arthritis.org/partnership/ease-of-use-certification
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240220492029/en/
Media Contacts – Organon
Karissa Peer, karissa.peer@organon.com Hannah Silver,
hannah.silver@organon.com
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