Coherus BioSciences, Inc. (“Coherus”, Nasdaq:
CHRS), today announced that YUSIMRY™ (adalimumab-aqvh) is now
available for commercial sale in the United States at a list price
of $995 per carton for two 40 mg/0.8 mL autoinjectors, representing
a discount of more than 85% to Humira® (adalimumab), currently
priced at $6,922 per carton of two pens.
“Adalimumab products are important medicines for the treatment
of serious autoimmune diseases, but cost is a barrier for many
patients. With the launch of YUSIMRY, patients are now able to
choose and access a high-quality, safe, and effective treatment at
significant savings compared to Humira,” said Denny Lanfear,
Coherus’ Chairman and Chief Executive Officer. “The price of Humira
is nearly $90,000 a year today, putting this important therapy out
of reach for many patients who are experiencing difficult financial
health challenges. Our price for YUSIMRY of less than $13,000 a
year was enabled by our investment in robust large-scale
manufacturing, allowing us to be a high-volume, low-cost adalimumab
biosimilar producer, ensuring reliable supply, and passing the
savings directly to patients in need.”
YUSIMRY is presented in a state-of-the-art autoinjector and
includes Coherus’ proprietary non-stinging, citrate-free
formulation and a 29-gauge needle. YUSIMRY, approved in 2021 by the
United States Food and Drug Administration (“FDA”), is a tumor
necrosis factor (“TNF”) blocker indicated to reduce the signs and
symptoms of rheumatoid arthritis, juvenile idiopathic arthritis,
psoriatic arthritis, and ankylosing spondylitis, and to treat
Crohn’s disease, ulcerative colitis, plaque psoriasis and
hidradenitis suppurativa. YUSIMRY Solutions™- Coherus’ patient
services platform – will ensure improved access and a fast and
seamless experience as patients start or switch to YUSIMRY
treatment based on a determination by their healthcare
provider.
About YUSIMRY
YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®
(adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated
to reduce the signs and symptoms of rheumatoid arthritis, juvenile
idiopathic arthritis, psoriatic arthritis, and ankylosing
spondylitis, and to treat Crohn’s disease, ulcerative colitis,
plaque psoriasis and hidradenitis suppurativa.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
YUSIMRY™ (adalimumab-aqvh) is biosimilar* to Humira®
(adalimumab injection).
WARNING: SERIOUS INFECTIONS AND
MALIGNANCYSee full prescribing information for
complete boxed warning.Patients treated with
YUSIMRY 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 YUSIMRY 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 YUSIMRY use and during therapy.
Initiate treatment for latent TB prior to YUSIMRY
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 YUSIMRY prior to initiating therapy in patients: 1. with
chronic or recurrent infection; 2. who have been exposed to TB; 3.
with a history of opportunistic infection; 4. who resided in or
traveled in regions where mycoses are endemic; 5. 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 YUSIMRY, including the possible
development of TB in patients who tested negative for latent TB
infection prior to initiating therapy.
Do not start YUSIMRY 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 tumor necrosis factor (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 YUSIMRY with other biologic disease-modifying
antirheumatic drugs (DMARDs) (e.g., anakinra or abatacept) or other
TNF blockers is not recommended based on the possible increased
risk for infections and other potential pharmacological
interactions as well as the lack of demonstrated benefit of such
combinations.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been
reported in children and adolescent patients treated with TNF
blockers, including adalimumab. 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. 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
YUSIMRY 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 plus ultraviolet A light
(PUVA) therapy, for the presence of NMSC prior to and during
treatment with YUSIMRY.
- 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 YUSIMRY and institute
appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
- Use of TNF blockers, including
adalimumab, 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 YUSIMRY
treatment.
- Discontinue YUSIMRY and begin
antiviral therapy in patients who develop HBV reactivation.
Exercise caution when resuming YUSIMRY after HBV treatment.
NEUROLOGIC REACTIONS
- TNF blockers, including adalimumab,
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
YUSIMRY for patients with these disorders; discontinuation of
YUSIMRY 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 blockers.
Medically significant cytopenia has been infrequently reported with
adalimumab.
- Consider stopping YUSIMRY 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; exercise caution
and monitor carefully.
AUTOIMMUNITY
- Treatment with YUSIMRY 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 YUSIMRY should not
receive live vaccines.
- Pediatric patients, if possible,
should be brought up to date with all immunizations before
initiating YUSIMRY 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 YUSIMRY 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
- Rheumatoid
Arthritis: YUSIMRY is indicated, alone or in combination
with methotrexate or other non-biologic 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: YUSIMRY 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: YUSIMRY 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: YUSIMRY is indicated for reducing signs and
symptoms in adult patients with active ankylosing spondylitis.
- Crohn’s Disease:
YUSIMRY 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: YUSIMRY is indicated for the treatment of
moderately to severely active ulcerative colitis in adult
patients.Limitations of Use:The effectiveness of YUSIMRY has not
been established in patients who have lost response to or were
intolerant to TNF blockers.
- Plaque Psoriasis:
YUSIMRY 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. YUSIMRY should only be administered
to patients who will be closely monitored and have regular
follow-up visits with a physician.
- Hidradenitis
Suppurativa: YUSIMRY is indicated for the treatment of
moderate to severe hidradenitis suppurativa in adult patients.
*Biosimilar means that the biological product is approved based
on data demonstrating that it is highly similar to an FDA-approved
biological product, known as a reference product, and that there
are no clinically meaningful differences between the biosimilar
product and the reference product. Biosimilarity of YUSIMRY has
been demonstrated for the condition(s) of use (e.g., indication(s),
dosing regimen(s)), strength(s), dosage form(s), and route(s) of
administration described in its Full Prescribing Information.
Click for YUSIMRY™ Full Prescribing
Information, including Boxed Warning and
Medication guide
About Coherus BioSciencesCoherus is a
commercial-stage biopharmaceutical company focused on the research,
development and commercialization of innovative immunotherapies to
treat cancer. Coherus’ strategy is to build a leading
immuno-oncology franchise funded with cash generated through net
sales of its diversified portfolio of FDA-approved
therapeutics.
In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody,
in the United States and Canada. The Biologics License Application
for toripalimab in combination with chemotherapy as treatment for
recurrent or metastatic nasopharyngeal carcinoma is currently under
review by the FDA.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of
Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®,
and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.
Forward-Looking StatementsExcept for the
historical information contained herein, the matters set forth in
this press release are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including, but not limited to,
statements regarding Coherus’ ability to build its immuno-oncology
franchise to achieve a leading market position; Coherus’ ability to
generate cash; Coherus’ investment plans; Coherus’ expectations for
the launch date of YUSIMRY™ and expectations for the future price
of YUSIMRY™.
Such forward-looking statements involve substantial risks and
uncertainties that could cause Coherus’ actual results,
performance, or achievements to differ significantly from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such risks and uncertainties
include, among others, risks related to our existing and potential
collaboration partners, the risks and uncertainties inherent in the
clinical drug development process; risks of the drug development
position of Coherus’ competitors; the risks and uncertainties of
the regulatory approval process, including the speed of regulatory
review, the risk of FDA review issues; and the risks and
uncertainties of possible litigation. All forward-looking
statements contained in this press release speak only as of the
date of this press release. Coherus undertakes no obligation to
update or revise any forward-looking statements. For a further
description of the significant risks and uncertainties that could
cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Coherus’
business in general, see Coherus’ Quarterly Report on Form 10-Q for
the fiscal quarter ended March 31, 2023, filed with the Securities
and Exchange Commission on May 8, 2023, including the section
therein captioned “Risk Factors” and in other documents that
Coherus files with the Securities and Exchange Commission.
UDENYCA®, CIMERLI® and YUSIMRY™, whether or not appearing in
large print or with the trademark symbol, are trademarks of
Coherus, its affiliates, related companies or its licensors or
joint venture partners unless otherwise noted. Trademarks and trade
names of other companies appearing in this press release are, to
the knowledge of Coherus, the property of their respective
owners.
Coherus Contact Information:For Investors:Marek
Ciszewski, J.D., SVP Investor RelationsIR@coherus.com
For Media:John Brandt, Rokk
Solutionscoherus@rokksolutions.com202-805-1830
Jodi Sievers, VP, Corporate Communicationsmedia@coherus.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/34c5db37-10e4-460d-b799-803d209cdbbe
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