Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Supplemental Biologics License Application
(sBLA) for the interchangeability designation for HADLIMA™
(adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira®
(adalimumab). The sBLA was submitted to the FDA by Samsung Bioepis
in August 2023.
The sBLA submission was based on clinical data
from the Phase 4, randomized, double-blind, 1:1 ratio,
parallel-group, multiple-dose, active comparator, multicenter
clinical study (NCT05510063) to assess the pharmacokinetic
similarity between two treatment groups: patients with moderate to
severe plaque psoriasis who switched multiple times between
high-concentration formulations of Humira and HADLIMA versus
patients receiving Humira continuously.1
“Following our announcement on the
interchangeability study’s topline results in August, we are
excited to share the progress on this sBLA filing on
interchangeability. This filing acceptance is a reinforcement of
our commitment to provide better access to biologic medicines for
patients in the United States,” said Byoung In Jung, Vice President
and Regulatory Affairs Team Leader at Samsung Bioepis. “We will
continue to drive our goal of realizing the value of biosimilars
for patients and contributing to the sustainability of healthcare
systems.”
“An interchangeability designation may play a
role beyond enabling pharmacy substitution. We believe that
interchangeability could help increase physician confidence with
prescribing biosimilars, especially in the high-concentration
formulation which is used by the majority of Humira patients. We
remain committed to helping more patients access biosimilar
alternatives,” said Jon Martin, Head, US Biosimilars at
Organon.
HADLIMA (adalimumab-bwwd) was first approved by the
FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation
of prefilled syringe and prefilled autoinjector. The
high-concentration (40 mg/0.4 mL) formulation of prefilled syringe
and prefilled autoinjector of HADLIMA was approved in August 2022.
HADLIMA was introduced into the US commercial market on July 1,
2023 and is marketed by Organon.
About InterchangeabilityBoth
biosimilars and interchangeable biosimilars have no clinically
meaningful differences in safety, purity, and potency as the
original biologic for approved indications.2 To be designated as
“interchangeable,” information must be submitted to show that:
- the biological product is
biosimilar to the reference product,
- the biological product can be
expected to produce the same clinical result as the reference
product in any given patient, and
- for a biological product that is
administered more than once to an individual, the risk in terms of
safety or diminished efficacy of alternating or switching between
use of the biological product and the reference product is not
greater than the risk of using the reference product without such
alternation or switch.3
Once a biosimilar product is designated as an
interchangeable biosimilar by the FDA, it can be used to replace
the reference product by someone other than the prescriber (such as
a pharmacist), without the need to consult the prescriber,
depending on the state pharmacy laws.2 This is similar to how
generic drugs are commonly substituted for brand name drugs.
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 adalimumab products 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 INFECTIONSPatients
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.
MALIGNANCYLymphoma 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.
HYPERSENSITIVITYAnaphylaxis and
angioneurotic edema have been reported following adalimumab
administration. If a serious allergic reaction occurs, stop HADLIMA
and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATIONUse
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 REACTIONSTNF 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 REACTIONSRare 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 FAILUREWorsening
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.
AUTOIMMUNITYTreatment 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.
IMMUNIZATIONSPatients 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 REACTIONSThe 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 Prescribing Information,
including the Boxed Warning about serious infections and
malignancies. The Medication Guide
and Instructions for Use
also are available.
About Samsung Bioepis Co.,
Ltd.Established in 2012, Samsung Bioepis is a
biopharmaceutical company committed to realizing health care that
is accessible to everyone. Through innovations in product
development and a firm commitment to quality, Samsung Bioepis aims
to become the world's leading biopharmaceutical company. Samsung
Bioepis continues to advance a broad pipeline of biosimilar
candidates that cover a spectrum of therapeutic areas, including
immunology, oncology, ophthalmology, hematology, and endocrinology.
For more information, please
visit: www.samsungbioepis.com and follow us on social
media – Twitter, LinkedIn.
About
OrganonOrganon is a global health care 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 and Instagram.
About the Samsung Bioepis-Organon
CollaborationHADLIMA is developed, manufactured and
supplied by Samsung Bioepis, and commercialized by Organon. Samsung
Bioepis and Organon have development and commercialization
collaborations for two immunology products and one oncology product
in the United States.
ORGANON, the Organon Logo, and HADLIMA are
trademarks of N.V. Organon. All other trademarks appearing herein
are trademarks of their respective owners.
Cautionary Note Regarding Forward-Looking
StatementsSome 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. 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; 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 the ongoing COVID-19 pandemic and
emergence of variant strains; 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; global tensions, which may
result in disruptions in the broader global economy; uncertainty
regarding the U.S. federal budget and debt ceiling, and the impact
of a potential U.S. federal government shutdown; governmental
initiatives that adversely impact our marketing activities,
particularly in China; 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; 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 Annual Report on Form 10-K for the year ended
December 31, 2022, and subsequent SEC filings, available at
the SEC’s Internet site (www.sec.gov).
1 Samsung Bioepis & Organon press release.
Samsung Bioepis & Organon Announce Topline Results from
Interchangeability Study of SB5 Humira Biosimilar. Issued on August
1, 2023.
https://www.globenewswire.com/news-release/2023/08/01/2715628/0/en/Samsung-Bioepis-Organon-Announce-Topline-Results-from-Interchangeability-Study-of-SB5-Humira-Biosimilar.html
2 The U.S. Food and Drug Administration. Biosimilar
and Interchangeable Biologics: More Treatment Choices.
https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.
Accessed September 2023
3 The U.S. Food and Drug Administration.
Considerations in Demonstrating Interchangeability With a Reference
Product Guidance for Industry.
https://www.fda.gov/media/124907/download. Accessed September
2023
Media Contacts – Samsung BioepisAnna Nayun Kim,
nayun86.kim@samsung.comJane Chung, ejane.chung@samsung.com
Media Contacts – OrganonKim Burke Hamilton,
kim.hamilton@organon.comKarissa Peer, karissa.peer@organon.com
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