Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN)
today announced the U.S. Food and Drug Administration (FDA) has
approved the citrate-free, high-concentration (100 mg/mL)
formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing
HUMIRA® (adalimumab). HADLIMA will be available in pre-filled
syringe and autoinjector options, and the autoinjector was
specifically designed with the patient in mind. HADLIMA was
previously approved by the FDA as a low-concentration (50 mg/mL)
formulation in July 2019 and outside the US that formulation has
been available in various markets globally under different brand
names, with over 5 million doses sold since 2018.1,2
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“With this approval, we now have both a low and high
concentration adalimumab biosimilar approved by the FDA, marking an
important step towards expanding treatment options for patients
suffering from certain chronic, autoimmune diseases,” said Byoungin
Jung, Vice President and Regulatory Affairs Team Leader, Samsung
Bioepis. “By leveraging our development expertise, manufacturing
excellence and supply chain reliability, we will continue our work
to ensure healthcare systems have more affordable treatment options
available,” she added.
“Based on our success commercializing our adalimumab biosimilar
in other markets around the world, combined with our established
presence in the biosimilar space, we are excited about the
opportunity to launch HADLIMA in the US in 2023,” said Joe
Azzinaro, Vice President, Global Commercial Lead Biosimilars,
Organon. “Today, adalimumab is the largest drug expense in the US.
We look forward to making our biosimilar available for those that
rely on it to help manage their disease.”
The approval of citrate-free, high-concentration HADLIMA was
based on clinical data from a randomized, single-blind, two-arm,
parallel group, single-dose study that compared the
pharmacokinetics, safety, tolerability, and immunogenicity of two
formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy
volunteers.3
HADLIMA is expected to be launched on or after July 1, 2023 by
Organon.
About Biosimilars
A biosimilar is a biologic product that is highly similar to and
has no clinically meaningful differences from an existing
FDA-approved reference product.4 Biologics are the fastest-growing
class of therapeutic products in the U.S., and biosimilars can
increase competition in the marketplace, potentially lowering
health care costs.4 Wider use of biosimilars could result in
savings of $100 billion in the U.S. between 2020 to 2024 by
stimulating market competition.5
About HADLIMA™ (adalimumab-bwwd)
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 anti-rheumatic 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 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.
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.
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.
Treatment with HADLIMA should not be initiated in patients with
an active infection, including localized infections. Patients 65
years of age and older, patients with co-morbid conditions and/or
patients taking concomitant immunosuppressants (such as
corticosteroids or methotrexate), may be at greater risk of
infection. Consider the risks and benefits of treatment prior to
initiating therapy in patients:
- with chronic or recurrent infection;
- who have been exposed to tuberculosis;
- with a history of an opportunistic infection;
- who have resided or traveled in areas of endemic tuberculosis
or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or
blastomycosis; or
- with underlying conditions that may predispose them to
infection.
Discontinue HADLIMA if a patient develops a serious infection or
sepsis. For a patient who develops a new infection during treatment
with HADLIMA, 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 HADLIMA 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 HADLIMA and other biologic
products for the treatment of RA, PsA, AS, CD, UC and Ps.
Concomitant administration of HADLIMA 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.
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
including HADLIMA 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 the controlled portions of clinical trials of some
TNF-blockers, including adalimumab products, more cases of
malignancies have been observed among TNF-blocker-treated adult
patients compared to control-treated adult patients.
- Non-melanoma skin cancer (NMSC) was reported during clinical
trials for adalimumab-treated patients. Examine all patients, and
in particular patients 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 HADLIMA.
- In the controlled portions of clinical trials of all the
TNF-blockers in adults, more cases of lymphoma have been observed
among TNF-blocker-treated patients compared to control-treated
patients. There was approximately a 3-fold higher than expected
rate 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 than the general population for
the development of lymphoma, even in the absence of TNF
blockers.
- Post-marketing cases of acute and chronic leukemia were
reported with TNF blocker use in RA and other indications.
- Malignancies, some fatal, have been reported among children,
adolescents, and young adults who received treatment with
TNF-blockers (initiation of therapy ≤ 18 years of age), of which
HADLIMA is a member. Approximately half the cases were lymphomas,
including Hodgkin's and non-Hodgkin's lymphoma. The 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 REACTIONS
- 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 HADLIMA and institute appropriate therapy. In
clinical trials of adalimumab, hypersensitivity reactions (e.g.,
rash, anaphylactoid reaction, fixed drug reaction, non-specified
drug reaction, urticaria) have been observed.
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. 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 monitor them during and after
HADLIMA treatment. Adequate data are not available on the safety or
efficacy of treating patients who are carriers of HBV with
anti-viral therapy in conjunction with TNF blocker therapy to
prevent HBV reactivation.
- In patients who develop HBV reactivation, stop HADLIMA and
initiate effective anti-viral 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 HADLIMA 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 and
optic neuritis, and peripheral demyelinating disease, including
Guillain-Barré syndrome.
- Exercise caution in considering the use of HADLIMA in patients
with preexisting or recent-onset central or peripheral nervous
system demyelinating disorders; discontinuation of HADLIMA should
be considered if any of these disorders develop.
HEMATOLOGICAL REACTIONS
- Rare reports of pancytopenia including aplastic anemia have
been reported with TNF blocking agents. Medically significant
cytopenia has been infrequently reported with HADLIMA.
- Adverse reactions of the hematologic system, including
medically significant cytopenia (e.g., thrombocytopenia,
leukopenia) have been infrequently reported with adalimumab
products. The causal relationship of these reports to adalimumab
products remains unclear. Advise all patients to seek immediate
medical attention if they develop signs and symptoms suggestive of
blood dyscrasias or infection (e.g., persistent fever, bruising,
bleeding, pallor) while on HADLIMA.
- Consider discontinuation of HADLIMA therapy in patients with
confirmed significant hematologic abnormalities.
INCREASED RISK OF INFECTION WHEN USED WITH ANAKINRA
- Concurrent use of anakinra (an interleukin-1 antagonist) and
another TNF-blocker, was associated with a greater proportion of
serious infections and neutropenia and no added benefit compared
with the TNF blocker alone in patients with RA. Therefore, the
combination of HADLIMA and anakinra is not recommended.
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. Adalimumab
products have not been formally studied in patients with CHF;
however, in clinical trials of another TNF blocker, a higher rate
of serious CHF-related adverse reactions was observed. Exercise
caution and monitor 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 HADLIMA, discontinue
treatment.
IMMUNIZATIONS
- Patients on HADLIMA may receive concurrent vaccinations, except
for live vaccines. No data are available on the secondary
transmission of infection by live vaccines in patients receiving
adalimumab products.
- 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 HADLIMA therapy.
Patients on HADLIMA may receive concurrent vaccinations, except for
live vaccines.
- 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 HADLIMA clinical trials
(>10%) were: infections (e.g., upper respiratory, sinusitis),
injection site reactions, headaches, and rash.
Before prescribing HADLIMA, please read the accompanying
Prescribing Information, including the Boxed Warning about serious
infections and malignancies. The Medication Guide is also
available.
About Samsung Bioepis Co.,
Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical
company committed to realizing healthcare 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, endocrinology, and gastroenterology. For
more information, please visit: www.samsungbioepis.com and follow
us on social media – Twitter, LinkedIn.
About Organon
Organon is a global healthcare company formed to focus on
improving the health of women throughout their lives. Organon has a
portfolio of more than 60 medicines and products across a range of
therapeutic areas. Led by the women’s health portfolio coupled with
an expanding biosimilars business and stable franchise of
established medicines, Organon’s products produce strong cash flows
that will support investments in innovation and future growth
opportunities. 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 9,300 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.
Forward-Looking
Statements
Except for historical information herein, this news release
includes “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 management’s expectations about Organon’s launch and
commercialization of HADLIMA and its collaboration with Samsung
Bioepis. Forward-looking statements may be identified by words such
as “expects,” “intends,” “anticipates,” “plans,” “believes,”
“seeks,” “estimates,” “will” or words of similar meaning. These
statements are based upon the current beliefs and expectations of
Organon‘s management and are subject to significant risks and
uncertainties. If underlying assumptions prove inaccurate or risks
or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, an
inability to execute on our business development strategy or
realize the benefits of our planned acquisitions; general economic
factors, including 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; Organon‘s ability to
accurately predict future market conditions; 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, 2021 and
subsequent SEC filings, available at the SEC’s Internet site
(www.sec.gov).
References and links to websites have been provided for
convenience, and the information contained on any such website is
not a part of, or incorporated by reference into, this press
release. Organon is not responsible for the contents of third-party
websites.
___________________________ 1 HADLIMA Label. August 16, 2022.
Available at
https://www.organon.com/wp-content/uploads/sites/2/2022/08/FDA_b761059_S005_Hadlima_8.15.22_letterlabeling_002_clean.pdf
2 IQVIA MIDAS data. Worldwide sales of SB5, Samsung Bioepis's
adalimumab biosimilar. As of March 2022 3 Ahn SS, Lee M, Baek Y,
Lee S. A randomized phase I pharmacokinetic study comparing
high-concentration, low-volume, and citrate-free SB5 (40 mg/0.4 mL)
with prior SB5 formulation, and adalimumab biosimilar, in healthy
male subjects. Presented at: EULAR 2022; June 1-4, 2022;
Copenhagen, Denmark. Abstract POS0641. 4 U.S. Food and Drug
Administration. Biosimilar and Interchangeable Products. Available
at:
https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products.
Accessed August 2022. 5 IQVIA Institute for Human Data Science.
(October 2020). “Biosimilars in the United States 2020–2024.”
https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024.
Accessed August 2022
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220816005432/en/
Media – Samsung Bioepis Anna
Nayun Kim, nayun86.kim@samsung.com Yoon Kim,
yoon1.kim@samsung.com
Media – Organon Karissa Peer, karissa.peer@organon.com
Hannah Silver, hannah.silver@organon.com Kim Burke Hamilton,
kim.hamilton@organon.com
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