Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today
announced topline results from the interchangeability study for
SB5, a biosimilar to Humira® (adalimumab). The Phase 4, randomized,
double-blind, parallel-group, multiple-dose, active comparator,
multicenter clinical study (NCT05510063) for SB5 was conducted
across 33 sites in four countries (Bulgaria, Czechia, Lithuania,
Poland) from August 2022 to May 2023 in patients with moderate to
severe chronic plaque psoriasis.
The primary objective of the study was to assess
the pharmacokinetic similarity between two treatment groups:
patients with moderate to severe plaque psoriasis who switched
multiple times between Humira (ADL) and high-concentration SB5
versus patients receiving ADL continuously. All 371 patients who
were enrolled in the study had no prior treatment with ADL and were
treated in this study with ADL during a lead-in period of 13 weeks.
At Week 13, patients who achieved at least a 50% reduction in
Psoriasis Area and Severity Index (PASI50) response were randomized
in a 1:1 ratio to either be switched between ADL and SB5 or
continue on ADL.
The study achieved all primary endpoints
(pharmacokinetic endpoints of AUCtau and Cmax at Week 23-25).1
Efficacy profiles, safety profiles, and immunogenicity were also
comparable between two treatment groups.
For comparisons of all primary endpoints (AUCtau,
23-25 wk and Cmax, 23-25 wk) between the multiple-switching group
and the ADL-continued group, the 90% confidence intervals (CI) were
fully included in the pre-defined margins; 90% CI for the ratio of
geometric least squares mean of AUCtau for Week 23-25 (0.8007,
1.1115) was included in the pre-defined margin of 0.8 and 1.25. 90%
CI for the ratio of geometric least squares mean of Cmax for Week
23-25 (0.8637, 1.1433) was also included in the pre-defined margin
of 0.8 and 1.25.
SB5 was first approved by the U.S. Food and Drug
Administration (FDA) in July 2019 under the brand name HADLIMA™
(adalimumab-bwwd) as a low-concentration (50 mg/mL) formulation of
prefilled syringe and prefilled autoinjector. The
high-concentration (100 mg/mL) formulation of prefilled syringe and
prefilled autoinjector of HADLIMA was approved in August 2022.
HADLIMA was introduced into the U.S. commercial market on July 1,
2023 and is marketed by Organon.
About HADLIMA™ (adalimumab-bwwd) Injection
40 mg/0.4 mL and 40 mg/0.8mL
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 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
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. 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; 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, available at the SEC’s Internet site
(www.sec.gov).
Media Contacts – Samsung
Bioepis
Anna Nayun Kim, nayun86.kim@samsung.com
Jane Chung, ejane.chung@samsung.com
Media Contacts – Organon
Karissa Peer, karissa.peer@organon.com
Hannah Silver, hannah.silver@organon.com
___________________________________
1 AUCtau, 23-25wk is the area under the
concentration-time curve over the dosing interval of week 23-25.
Cmax, 23-25wk is the maximum serum concentration during the dosing
interval of week 23-25.
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