TEL AVIV, Israel & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)--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
- 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
- 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
- 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
- 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
- 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.
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.
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.