HERZUMA is a biosimilar to HERCEPTIN®1
(trastuzumab)
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion
Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that
HERZUMA®1 (trastuzumab-pkrb) for Injection, a biosimilar to
HERCEPTIN®1, is now available in the United States with the same
indications as the reference product including:
- Adjuvant Breast Cancer HERZUMA is indicated for the
adjuvant treatment of HER2-overexpressing node-positive or
node-negative (ER/PR negative or with one high-risk feature) breast
cancer
- as part of a treatment regimen consisting of doxorubicin,
cyclophosphamide, and either paclitaxel or docetaxel
- as part of a treatment regimen with docetaxel and
carboplatin
- as a single agent following multi-modality anthracycline based
therapy
- Metastatic Breast Cancer HERZUMA is indicated:
- In combination with paclitaxel for first-line treatment of
HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast
cancer in patients who have received one or more chemotherapy
regimens for metastatic disease
- Metastatic Gastric Cancer HERZUMA is indicated in
combination with cisplatin and capecitabine or 5-fluorouracil, for
the treatment of patients with HER2-overexpressing metastatic
gastric or gastroesophageal junction adenocarcinoma who have not
received prior treatment for metastatic disease.
In these indications, patients should be selected for therapy
based on a U.S. Food and Drug Administration (FDA)-approved
companion diagnostic for a trastuzumab product.
“We are proud to make HERZUMA available to patients in the U.S.
living with HER2-positive breast and gastric cancers, and their
providers,” said Brendan O’Grady, Executive Vice President, North
America Commercial, Teva. “The launch of HERZUMA continues our
commitment to help lower healthcare costs and increase price
competition through the availability of biosimilars. Teva is
continuing to invest in biopharmaceuticals as part of our long-term
strategy for the future, and to help patients around the world, and
we look forward to additional milestones for our biosimilar
products later this year.”
HERZUMA has received FDA approval for the same indications of
the reference product.
“We are pleased that HERZUMA is now available to patients in the
U.S.,” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion
Healthcare. “We look forward to continuing our partnership with
Teva to bring biosimilars to as many patients as possible in the
U.S., as we believe they address an unmet need in the market.”
The Wholesale Acquisition Cost (WAC or “list price”) for HERZUMA
150 mg is $1,402.50 and HERZUMA 420 mg is $3,927, which is a 10
percent discount to the WAC of HERCEPTIN®. Actual costs to
individual patients and providers for HERZUMA are anticipated to be
lower than WAC because WAC does not account for additional rebates
and discounts that may apply. Savings on out-of-pocket costs may
vary depending on the patient’s insurance payer and eligibility for
participation in the assistance program.
Dedicated patient support services are also available from Teva
through the CORE program. CORE is available to help eligible
patients, caregivers and healthcare professionals navigate the
reimbursement process. CORE offers a range of services, including
benefits verification and coverage determination, support for
precertification and prior authorization, assistance with coverage
guidelines and claims investigation, and support through the claims
and appeals process. A savings program is also available for
eligible commercially insured patients. To learn more, please visit
TevaCORE.com.
Celltrion Healthcare and Teva Pharmaceutical Industries Ltd.
entered into an exclusive partnership in October 2016 for Teva to
commercialize HERZUMA in the U.S. and Canada.
Trastuzumab products have a Boxed Warning, which states that
treatment with trastuzumab may be associated with cardiomyopathy,
infusion reactions, pulmonary toxicity and embryo-fetal toxicity.
Please see the full Boxed Warning and additional Important Safety
Information in this release and accompanying Prescribing
Information.
Important Safety Information
WARNING: CARDIOMYOPATHY, INFUSION
REACTIONS, EMBRYO‑FETAL TOXICITY, AND PULMONARY TOXICITY
Cardiomyopathy - Administration of
trastuzumab products can result in sub-clinical and clinical
cardiac failure. The incidence and severity was highest in patients
receiving trastuzumab with anthracycline‑containing chemotherapy
regimens.
Evaluate left ventricular function in all
patients prior to and during treatment with HERZUMA. Discontinue
HERZUMA treatment in patients receiving adjuvant therapy and
withhold HERZUMA in patients with metastatic disease for clinically
significant decrease in left ventricular function.
Infusion Reactions; Pulmonary Toxicity
- Administration of trastuzumab products can result in serious
and fatal infusion reactions and pulmonary toxicity. Symptoms
usually occur during or within 24 hours of administration.
Interrupt HERZUMA infusion for dyspnea or clinically significant
hypotension. Monitor patients until symptoms completely resolve.
Discontinue HERZUMA for anaphylaxis, angioedema, interstitial
pneumonitis, or acute respiratory distress syndrome.
Embryo-Fetal Toxicity - Exposure to
trastuzumab products during pregnancy can result in oligohydramnios
and oligohydramnios sequence manifesting as pulmonary hypoplasia,
skeletal abnormalities, and neonatal death. Advise patients of
these risks and the need for effective contraception.
WARNINGS AND PRECAUTIONS
Cardiomyopathy
- Administration of trastuzumab products can result in
sub-clinical and clinical cardiac failure. The incidence and
severity was highest in patients receiving trastuzumab with
anthracycline‑containing chemotherapy regimens
- Trastuzumab products can cause left ventricular cardiac
dysfunction, arrhythmias, hypertension, disabling cardiac failure,
cardiomyopathy, and cardiac death
- Trastuzumab products can also cause asymptomatic decline in
left ventricular ejection fraction (LVEF)
- Discontinue HERZUMA treatment in patients receiving adjuvant
therapy and withhold HERZUMA in patients with metastatic disease
for clinically significant decrease in left ventricular
function
- The safety of continuation or resumption of HERZUMA in patients
with trastuzumab product-induced LV cardiac dysfunction has not
been studied
Cardiac Monitoring
- Evaluate cardiac function prior to and during treatment. For
adjuvant breast cancer therapy, also evaluate cardiac function
after completion of HERZUMA
- Conduct thorough cardiac assessment, including history,
physical examination, and determination of LVEF by echocardiogram
or MUGA scan
- Monitor frequently for decreased left ventricular function
during and after HERZUMA treatment
- Monitor more frequently if HERZUMA is withheld for significant
left ventricular cardiac dysfunction
Infusion Reactions
- Administration of trastuzumab products can result in serious
and fatal infusion reactions
- Symptoms usually occur during or within 24 hours of
administration
- Interrupt HERZUMA infusion for dyspnea or clinically
significant hypotension
- Monitor patients until symptoms completely resolve
- Discontinue HERZUMA for anaphylaxis or angioedema. Strongly
consider permanent discontinuation in all patients with severe
infusion reactions
- Infusion reactions consist of a symptom complex characterized
by fever and chills, and on occasion included nausea, vomiting,
pain (in some cases at tumor sites), headache, dizziness, dyspnea,
hypotension, rash, and asthenia
Embryo-Fetal Toxicity
- Exposure to trastuzumab products during pregnancy can result
in oligohydramnios and oligohydramnios sequence manifesting as
pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Advise patients of these risks and the need for effective
contraception
- Verify the pregnancy status of females of reproductive
potential prior to the initiation of HERZUMA
- Advise pregnant women and females of reproductive potential
that exposure to HERZUMA during pregnancy or within 7 months prior
to conception can result in fetal harm
- Advise females of reproductive potential to use effective
contraception during treatment and for 7 months following the last
dose of HERZUMA. Advise female patients to contact their healthcare
provider with a known or suspected pregnancy
- Consider the developmental and health benefits of breastfeeding
along with the mother’s clinical need for HERZUMA treatment and any
potential adverse effects on the breastfed child from HERZUMA or
from the underlying maternal condition
Pulmonary Toxicity
- Administration of trastuzumab products can result in serious
and fatal pulmonary toxicity, which includes dyspnea,
interstitial pneumonitis, pulmonary infiltrates, pleural effusions,
non‑cardiogenic pulmonary edema, pulmonary insufficiency and
hypoxia, acute respiratory distress syndrome, and pulmonary
fibrosis. Such events can occur as sequelae of infusion
reactions
- Patients with symptomatic intrinsic lung disease or with
extensive tumor involvement of the lungs, resulting in dyspnea at
rest, appear to have more severe toxicity
- Discontinue HERZUMA in patients experiencing pulmonary
toxicity
Exacerbation of Chemotherapy-Induced Neutropenia
- In randomized, controlled clinical trials, the per-patient
incidences of NCI-CTC Grade 3 to 4 neutropenia and of febrile
neutropenia were higher in patients receiving trastuzumab in
combination with myelosuppressive chemotherapy as compared to those
who received chemotherapy alone. The incidence of septic death was
similar among patients who received trastuzumab and those who did
not
Most Common Adverse Reactions
- Adjuvant Breast Cancer - Most common adverse reactions
(≥5%) are headache, diarrhea, nausea, and chills
- Metastatic Breast Cancer- Most common adverse reactions
(≥10%) are fever, chills, headache, infection, congestive heart
failure, insomnia, cough, and rash
- Metastatic Gastric Cancer- Most common adverse reactions
(≥10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis,
weight loss, upper respiratory tract infections, fever,
thrombocytopenia, mucosal inflammation, nasopharyngitis, and
dysgeusia
Please click here for full Prescribing Information for HERZUMA,
including BOXED WARNINGS.
About HERZUMA®
HERZUMA (trastuzumab-pkrb) for Injection is a U.S. FDA-approved
biosimilar to Herceptin® with no clinically meaningful differences
in safety, purity and potency. HERZUMA is used in adults to treat
HER2+ breast cancer and metastatic gastric cancer. HERZUMA has the
same mechanism of action as Herceptin and has demonstrated
biosimilarity to Herceptin through a totality of evidence.
About Celltrion Healthcare, Co. Ltd.
Celltrion Healthcare conducts the worldwide marketing, sales and
distribution of biological medicines developed by Celltrion, Inc.
through an extensive global network that spans more than 120
different countries. Celltrion Healthcare’s products are
manufactured at state-of-the-art mammalian cell culture facilities,
designed and built to comply with the US FDA cGMP guidelines and
the EU GMP guidelines.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the U.S. Availability of HERZUMA®, which are based on
management’s current beliefs and expectations and are subject to
substantial risks and uncertainties, both known and unknown, that
could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- the commercial success of HERZUMA;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations and the effectiveness of our
patents and other measures to protect our intellectual property
rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including:
implementation of our restructuring plan announced in December
2017; our ability to attract, hire and retain highly skilled
personnel; our ability to develop and commercialize additional
pharmaceutical products; compliance with anti-corruption, sanctions
and trade control laws; manufacturing or quality control problems;
interruptions in our supply chain including due to potential
effects of the COVID-19 outbreak on our operations in geographic
locations impacted by the outbreak and on the business operations
of our customers and suppliers; disruptions of information
technology systems; breaches of our data security; variations in
intellectual property laws; challenges associated with conducting
business globally, including adverse effects of political or
economic instability, major hostilities or terrorism; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including:
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications in the U.S. and our
ability to reach a final resolution of the remaining opioid-related
litigation; costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into S&M practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in our Annual Report on Form 10-K
for the year ended December 31, 2019, including in the sections
captioned "Risk Factors” and “Forward Looking Statements.”
Forward-looking statements speak only as of the date on which they
are made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
1Herceptin ® (trastuzumab) is a registered trademark of
Genentech.
2 Herzuma (trastuzumab-pkrb) for injection, for intravenous use
Prescribing Information. Incheon, Republic of Korea; Celltrion
Inc.
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