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JERUSALEM & PARSIPPANY, N.J. & INCHEON, South Korea–(BUSINESS WIRE)–Teva Pharmaceuticals USA, Inc., a U.S. associate of Teva Biologic Industries Ltd. (NYSE and TASE: TEVA), Celltrion, Inc., (KRX KRX:068270) and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today arise that TRUXIMA® (rituximab-abbs) bang is the aboriginal biosimilar to the advertence artefact Rituxan®1 (rituximab) now attainable in the United States with a abounding oncology label. TRUXIMA is currently adumbrated for the analysis of developed patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL):



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“We are aflame about the aboriginal FDA-approved biosimilar to rituximab in the U.S.,” declared Brendan O’Grady, Executive Vice President and Head of North America Bartering at Teva. “Teva’s charge to biosimilars is focused on the abeyant to actualize lower healthcare costs and added amount competition. This focus is constant with Teva’s mission of authoritative attainable medications to advice advance the lives of patients.”

TRUXIMA was accustomed by the U.S. Food and Drug Administering (FDA) as the aboriginal rituximab biosimilar. The approval was based on a analysis of a absolute abstracts amalgamation across-the-board of basal and all-encompassing analytic characterization, nonclinical data, analytic pharmacology, immunogenicity, analytic efficacy, and assurance data. In May 2019, the FDA accustomed TRUXIMA to bout all of the advertence product’s oncology break for NHL and CLL. In ablaze of a apparent adjustment with Genentech, Celltrion and Teva accept a awaiting FDA acquiescence for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and diminutive polyangiitis (MPA), and a allotment from Genentech to aggrandize the TRUXIMA assuming to accommodate these break in Q2 2020.



“We are admiring to advertise the barrage of the aboriginal rituximab biosimilar, TRUXIMA, with our business accomplice Teva in the U.S.” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We accept that the addition of TRUXIMA into the U.S. bazaar will accord to acclamation unmet needs of U.S. patients as well.”

The Wholesale Accretion Cost (WAC or “list price”) for TRUXIMA will be 10 percent lower than the advertence product. TRUXIMA is actuality fabricated attainable through primary wholesalers at a WAC of $845.55 for 100mg canteen and $4227.75 for 500mg vial. Actual costs to alone patients and providers for TRUXIMA are advancing to be lower than WAC because WAC does not annual for added rebates and discounts that may apply. Accumulation on abroad costs may alter depending on the patient’s allowance payer and accommodation for accord in the abetment program.



Dedicated accommodating abutment casework are additionally attainable from Teva through the Absolute Oncology Agreement Adeptness (CORE) program. CORE is attainable to advice acceptable patients, caregivers and healthcare professionals cross the agreement process. CORE offers a ambit of services, including allowances analysis and advantage determination, abutment for precertification and above-mentioned authorization, abetment with advantage guidelines and claims investigation, and abutment through the claims and appeals process. A accumulation affairs is additionally attainable for acceptable commercially insured patients. To apprentice more, amuse appointment Media For healthcare professionals gluttonous added information, there is additionally a committed armpit at Media and Teva Biologic Industries Ltd. entered into an absolute affiliation in October 2016 to commercialize TRUXIMA in the U.S. and Canada.

Please see the Important Assurance Advice beneath including the Boxed Warning apropos baleful infusion-related reactions, astringent mucocutaneous reactions, hepatitis B virus reactivation and accelerating multifocal leukoencephalopathy. For added information, amuse appointment the abounding prescribing information.

Important Assurance Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

 

Infusion-Related Reactions – Administering of rituximab products, including TRUXIMA, can aftereffect in serious, including fatal, infusion-related reactions. Deaths aural 24 hours of rituximab beverage accept occurred. Approximately 80% of baleful infusion-related reactions occurred in affiliation with the aboriginal infusion. Adviser patients closely. Abandon TRUXIMA beverage for astringent reactions and accommodate medical analysis for Brand 3 or 4 infusion-related reactions

 

Severe Mucocutaneous Reactions – Severe, including fatal, mucocutaneous reactions can activity in patients accepting rituximab articles

 

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Hepatitis B Virus (HBV) Reactivation – HBV reactivation can activity in patients advised with rituximab products, in some cases consistent in atomic hepatitis, hepatic failure, and death. Screen all patients for HBV infection afore analysis initiation, and adviser patients during and afterwards analysis with TRUXIMA. Abandon TRUXIMA and accessory medications in the accident of HBV reactivation

 

Progressive Multifocal Leukoencephalopathy (PML), including baleful PML, can activity in patients accepting rituximab products

Warnings and Precautions

Infusion-Related Reactions – Rituximab articles can account severe, including fatal, infusion-related reactions. Astringent reactions about occurred during the aboriginal beverage with time to admission of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae accommodate urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, astute respiratory ache syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.

Premedicate patients with an antihistamine and acetaminophen above-mentioned to dosing. Convention medical administering (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related acknowledgment and the adapted interventions, briefly or assuredly abandon TRUXIMA. Resume beverage at a minimum 50% abridgement in amount afterwards affection accept resolved. Carefully adviser the afterward patients: those with above-mentioned cardiac or pulmonary conditions, those who accomplished above-mentioned cardiopulmonary adverse reactions, and those with aerial numbers of circulating cancerous beef (>25,000/mm3)

Severe Mucocutaneous Reactions – Mucocutaneous reactions, some with baleful outcome, can activity in patients advised with rituximab products. These reactions accommodate paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and baneful epidermal necrolysis. The admission of these reactions has been capricious and includes letters with admission on the aboriginal day of rituximab exposure. Abandon TRUXIMA in patients who acquaintance a astringent mucocutaneous reaction. The assurance of re-administration of rituximab articles to patients with astringent mucocutaneous reactions has not been determined.

Hepatitis B Virus Reactivation – Hepatitis B virus (HBV) reactivation, in some cases consistent in atomic hepatitis, hepatic abortion and death, can activity in patients advised with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases accept been arise in patients who are hepatitis B apparent antigen (HBsAg) absolute and additionally in patients who are HBsAg abrogating but are hepatitis B amount antibiotic (anti-HBc) positive. Reactivation additionally has occurred in patients who arise to accept bound hepatitis B infection (i.e., HBsAg negative, anti-HBc absolute and hepatitis B apparent antibiotic [anti-HBs] positive).

HBV reactivation is authentic as an brusque admission in HBV archetype manifesting as a accelerated admission in serum HBV DNA levels or apprehension of HBsAg in a being who was ahead HBsAg abrogating and anti-HBc positive. Reactivation of HBV archetype is generally followed by hepatitis, i.e., admission in transaminase levels. In astringent cases admission in bilirubin levels, alarmist failure, and afterlife can occur.

Screen all patients for HBV infection by barometer HBsAg and anti-HBc afore initiating analysis with TRUXIMA. For patients who appearance affirmation of above-mentioned hepatitis B infection (HBsAg absolute [regardless of antibiotic status] or HBsAg abrogating but anti-HBc positive), argue with physicians with adeptness in managing hepatitis B apropos ecology and application for HBV antiviral analysis afore and/or during TRUXIMA treatment.

Monitor patients with affirmation of accepted or above-mentioned HBV infection for analytic and class signs of hepatitis or HBV reactivation during and for several months afterward TRUXIMA therapy. HBV reactivation has been arise up to 24 months afterward achievement of rituximab therapy.

In patients who advance reactivation of HBV while on TRUXIMA, anon abandon TRUXIMA and any accessory chemotherapy, and convention adapted treatment. Insufficient abstracts abide apropos the assurance of resuming TRUXIMA analysis in patients who advance HBV reactivation. Resumption of TRUXIMA analysis in patients whose HBV reactivation resolves should be discussed with physicians with adeptness in managing HBV.

Progressive Multifocal Leukoencephalopathy (PML) – JC virus infection consistent in PML and afterlife can activity in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML accustomed rituximab in aggregate with chemotherapy or as allotment of a hematopoietic axis corpuscle transplant. Best cases of PML were diagnosed aural 12 months of their aftermost beverage of rituximab.

Consider the analysis of PML in any accommodating presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not bound to, appointment with a neurologist, academician MRI, and lumbar puncture.

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Discontinue TRUXIMA and accede cessation or abridgement of any accessory chemotherapy or immunosuppressive analysis in patients who advance PML.

Tumor Lysis Affection (TLS) – Astute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from bump lysis, sometimes fatal, can activity aural 12-24 hours afterwards the aboriginal beverage of rituximab articles in patients with NHL. A aerial cardinal of circulating cancerous beef (>25,000/mm3) or aerial bump burden, confers a greater accident of TLS.

Administer advancing intravenous hydration and anti-hyperuricemic analysis in patients at aerial accident for TLS. Correct electrolyte abnormalities, adviser renal activity and aqueous balance, and administrate admiring care, including dialysis as indicated.

Infections – Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can activity during and afterward the achievement of rituximab product-based therapy. Infections accept been arise in some patients with abiding hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months afterwards rituximab exposure). New or reactivated viral infections included cytomegalovirus, canker canker virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Abandon TRUXIMA for austere infections and convention adapted anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, alive infections.

Cardiovascular Adverse Reactions – Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may activity in patients accepting rituximab products. Abandon infusions for austere or life-threatening cardiac arrhythmias. Perform cardiac ecology during and afterwards all infusions of TRUXIMA for patients who advance clinically cogent arrhythmias, or who accept a history of arrhythmia or angina.

Renal Toxicity – Severe, including fatal, renal toxicity can activity afterwards rituximab artefact administering in patients with NHL. Renal toxicity has occurred in patients who acquaintance bump lysis affection and in patients with NHL administered accessory cisplatin analysis during analytic trials. The aggregate of cisplatin and TRUXIMA is not an accustomed analysis regimen. Adviser carefully for signs of renal abortion and abandon TRUXIMA in patients with a ascent serum creatinine or oliguria.

Bowel Obstruction and Breach – Belly pain, bowel obstruction and perforation, in some cases arch to death, can activity in patients accepting rituximab in aggregate with chemotherapy. In postmarketing reports, the beggarly time to accurate gastrointestinal breach was 6 (range 1-77) canicule in patients with NHL. Evaluate if affection of obstruction such as belly affliction or again airsickness occur.

Immunization – The assurance of immunization with alive viral vaccines afterward rituximab artefact analysis has not been advised and anesthetic with alive virus vaccines is not recommended afore or during treatment.

Embryo-Fetal Toxicity – Based on animal data, rituximab articles can account fetal corruption due to B-cell lymphocytopenia in breed apparent to rituximab in-utero. Admonish abundant women of the accident to a fetus. Females of bearing abeyant should use able contraception while accepting TRUXIMA and for 12 months afterward the aftermost dosage of TRUXIMA.

Most accepted adverse reactions in analytic trials of NHL (>25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most accepted adverse reactions in analytic trials of CLL (>25%) were: infusion-related reactions and neutropenia

Nursing Mothers – There are no abstracts on the attendance of rituximab in animal milk, the aftereffect on the breastfed child, or the aftereffect on milk production. Since abounding drugs including antibodies are present in animal milk, admonish a lactating woman not to breastfeed during analysis and for at atomic 6 months afterwards the aftermost dosage of TRUXIMA due to the abeyant for austere adverse reactions in breastfed infants.

About TRUXIMA®

TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administering (FDA)-approved biosimilar to RITUXAN® (rituximab) for the analysis of developed patients with CD20-positive, B-cell NHL to be acclimated as a distinct abettor or in aggregate with chemotherapy or CLL in aggregate with fludarabine and cyclophosphamide (FC).

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TRUXIMA has the aforementioned apparatus of activity as Rituxan and has approved biosimilarity to Rituxan through a accumulation of evidence.

About Celltrion Healthcare, Co. Ltd.

Celltrion Healthcare conducts the common marketing, sales and administration of biological medicines developed by Celltrion, Inc. through an all-encompassing all-around arrangement that spans added than 120 altered countries. Celltrion Healthcare’s articles are bogus at avant-garde beastly corpuscle adeptness facilities, advised and congenital to accede with the US Food and Drug Administering (FDA) cGMP guidelines and the EU GMP guidelines.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a arch biopharmaceutical company, specializing in research, development and accomplishment of biosimilar and avant-garde drugs. Celltrion strives to accommodate added affordable biosimilar mAbs to patients who ahead had bound admission to avant-garde therapeutics. Celltrion accustomed FDA approval for TRUXIMA® (rituximab-abbs) and HERZUMA® (trastuzumab-pkrb) in 2018.

About Teva

Teva Biologic Industries Ltd. (NYSE and TASE: TEVA) has been developing and bearing medicines to advance people’s lives for added than a century. We are a all-around baton in all-encompassing and specialty medicines with a portfolio consisting of over 3,500 articles in about every ameliorative area. About 200 actor bodies about the apple booty a Teva anesthetic every day, and are served by one of the better and best circuitous accumulation chains in the biologic industry. Along with our accustomed attendance in generics, we accept cogent avant-garde analysis and operations acknowledging our growing portfolio of specialty and biopharmaceutical products. Apprentice added at Media Cautionary Note Apropos Forward-Looking Statements

This columnist absolution contains advanced statements aural the acceptation of the Private Securities Activity Reform Act of 1995 apropos TRUXIMA®, which are based on management’s accepted behavior and expectations and are accountable to abundant risks and uncertainties, both accepted and unknown, that could account our approaching results, achievement or achievements to alter decidedly from that bidding or adumbrated by such advanced statements. Important factors that could account or accord to such differences accommodate risks apropos to:

and added factors discussed in our Quarterly Letters on Form 10-Q for the aboriginal and additional division of 2019 and in our Annual Report on Form 10-K for the year concluded December 31, 2018, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Advanced statements allege alone as of the date on which they are made, and we accept no obligation to amend or alter any advanced statements or added advice independent herein, whether as a aftereffect of new information, approaching contest or otherwise. You are cautioned not to put disproportionate assurance on these advanced statements.

1 RITUXAN is a registered brand of Genentech and Biogen.

IR
United States
Kevin C. Mannix (215) 591-8912

Ran Meir 972 (3) 926-7516

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United States
Doris Li (973) 265-3752

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