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:
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
Exacerbation of Chemotherapy-Induced Neutropenia
Most Common Adverse Reactions
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:
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.
Kevin C. Mannix
972 (3) 926-7516
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Source: Teva Pharmaceuticals USA, Inc.
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