טבע וסלטריון מודיעות על זמינות TRUXIMA® (rituximab-abbs) בהזרקה, גרסת הביוסימילר הראשונה של Rituxan® (rituximab) בארה"ב

TRUXIMA יהיה זמין בשוק החל מהשבוע של ה- 11 בנובמבר

7 נוב 2019 | זמן קריאה ממוצע: 10 דקות

ירושלים ופרסיפני ניו ג'רזי ואינצ'און, דרום קוריאה, 7 בנובמבר 2019 - טבע ארה"ב פרמצבטיקה בע"מ, חברה בת של טבע תעשיות פרמצבטיות בע"מ  (NYSE and TASE: TEVA) ו- (Celltrion Healthcare, Co., Ltd (KRX KOSDAQ:091990  הודיעו היום כי (TRUXIMA® (rituximab-abbs בהזרקה, היא גרסת  הביוסימילר הראשונה למוצר המקור (Rituxan®[1] (rituximab הזמינה כעת בארה"ב עם התוויה אונקולוגית מלאה. TRUXIMA מותווית לטיפול במטופלים בגירים עם לימפומה שאינה הודג'קין (NHL) ולוקמיה לימפוציטית כרונית (CLL):

 

  • Non-Hodgkin’s Lymphoma (NHL)
    • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent
    • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
    • Non-progressing (including stable disease), low-grade, CD20­positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
    • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens

 

  • Chronic Lymphocytic Leukemia (CLL)
    • In combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL

 

"אנו מאוד שמחים על תרופת הביוסימילר הראשונה שלrituximab  שאושרה על ידי ה- FDA בארה"ב," אמר ברנדן או'גרידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה בטבע. "המחויבות של טבע לתרופות ביוסימילריות מתמקדת בפוטנציאל להביא לעלויות בריאות נמוכות יותר ולתחרות מחירים מוגברת. מיקוד זה עולה בקנה אחד עם המשימה של טבע להנגשת תרופות בכדי לשפר את חייהם של מטופלים. "

 

TRUXIMA אושר על ידי מינהל המזון והתרופות האמריקני (FDA) כביוסימילר הראשון של rituximab. האישור התבסס על סקירת חבילת נתונים מקיפה הכוללת אפיון אנליטי בסיסי ורחב, נתונים לא קליניים, פרמקולוגיה קלינית, אימונוגניות, יעילות קלינית ונתוני בטיחות. בחודש מאי 2019, ה- FDA אישר את TRUXIMA עם התאמה לכל ההתוויות האונקולוגיות של מוצר המקור עבור NHL ו- CLL. לאור הסדר פטנטים עם ג'ננטק, לסלטריון ולטבע יש הגשת FDA ​​תלויה ועומדת עבור דלקת מפרקים שגרונית (RA), גרנולומטוזיס עם פוליאנגאיטיס (GPA) ופוליאנגיטיס מיקרוסקופי (MPA), ורשיון מג'ננטק להרחיב את התוויית TRUXIMA לכלול אינדיקציות אלה ברבעון השני של 2020.

 

"אנו שמחים להודיע על השקת TRUXIMA, תרופת הביוסימילר הראשונה של rituximab, יחד עם טבע, השותפה שלנו לשיווק בארה"ב," אמר מר היונג קי-קים, סגן יו"ר בחברת Celltrion Healthcare. "אנו מאמינים כי הכנסת TRUXIMA לשוק בארה"ב תסייע להתמודד עם צרכים שאין להם מענה עבור מטופלים בארה"ב."

 

עלות הרכישה הסיטונית (WAC או "מחיר מחירון") עבור TRUXIMA תהיה נמוכה בעשרה אחוזים ממוצר הייחוס. TRUXIMA הופכת לזמינה באמצעות סיטונאים ראשוניים במחיר WAC של 845.55 דולר עבור בקבוקון 100 מ"ג ו-  4227.72 דולר עבור בקבוקון 500 מ"ג. העלויות בפועל לחולים ולספקים פרטיים עבור TRUXIMA צפויות להיות נמוכות מ- WAC מכיוון ש- WAC אינו כולל הנחות נוספות והחזרים שעשויים לחול. החיסכון בעלות עבור המטופל עשוי למבטח של המטופל וזכאות להשתתפות בתוכנית הסיוע.

 

 

שירותי תמיכה ייעודיים לחולים זמינים גם מטבע באמצעות התוכנית המקיפה להחזרת הוצאות באונקולוגיה (CORE). CORE זמינה כדי לעזור לחולים זכאים, מטפלים ואנשי מקצוע בתחום הבריאות לנווט בתהליך ההחזר. CORE מציעה מגוון שירותים, כולל אימות הטבות וקביעת הכיסוי, תמיכה באישור מראש, סיוע בהנחיות הכיסוי ותמיכה בתהליך התביעות והערעורים. תכנית חיסכון זמינה גם עבור חולים מבוטחים מסחריים זכאים. למידע נוסף בקרו באתר TevaCORE.com. עבור אנשי מקצוע בתחום הבריאות המחפשים מידע נוסף, יש גם אתר ייעודי בכתובת TRUXIMAhcp.com.

 

סלטריון וטבע תעשיות פרמצבטיות בע"מ נכנסו לשותפות בלעדית באוקטובר 2016 במטרה למסחר את TRUXIMA בארה"ב ובקנדה.

 

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please visit the full prescribing information.

 

Important Safety Information

 

 

Warnings and Precautions

 

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.

 

Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (>25,000/mm3)

 

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis.  The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure.  Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined.

 

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).

 

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur.

 

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment.

 

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy.

 

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

 

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.

 

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture.

 

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL.  A high number of circulating malignant cells (>25,000/mm3) or high tumor burden, confers a greater risk of TLS.

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS.  Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

 

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections.

 

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias.  Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

 

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria.

 

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

 

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

 

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA.

 

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

 

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

 

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants.

 

About TRUXIMA®

TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN® (rituximab) for the treatment of adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC).

 

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan 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 Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

 

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA approval for TRUXIMA® (rituximab-abbs) and HERZUMA® (trastuzumab-pkrb) in 2018. 

 

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) מפתחת ומייצרת תרופות לשיפור חייהם של אנשים מזה למעלה ממאה שנה. אנו מובילים גלובליים בגנריקה ובתרופות ייחודיות, עם פורטפוליו הכולל יותר מ- 3,500 מוצרים בכמעט כל תחום טיפולי. בכל יום, קרוב ל-200 מיליון אנשים ברחבי העולם נוטלים תרופה של טבע, הודות לאחת ממערכות התפעול הגדולות והמורכבות בתעשייה הפרמצבטית. נוסף על מעמדנו המבוסס בגנריקה, יש לנו פעילות מחקר חדשני משמעותית התומכת בפורטפוליו המוצרים הייחודיים והביופרמצבטיים הגדל שלנו. למידע נוסף על החברה, בקרו באתר www.Teva.co.il



[1] RITUXAN® is a registered trademark of Genentech and Biogen.

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 TRUXIMA®, 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 TRUXIMA;

 

  • challenges inherent in product research and development, including obtaining regulatory approvals for additional indications for TRUXIMA;

 

  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; 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; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; 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: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; 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 in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; implementation of a new enterprise resource planning system that, if deficient, could materially and adversely affect our operations and/or the effectiveness of our internal controls; and our prospects and opportunities for growth if we sell assets ;

 

  • compliance, regulatory and litigation matters, including: 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; increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S.; governmental investigations into selling and marketing 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 Quarterly Reports on Form 10-Q for the first and  second quarter  of 2019  and in our Annual Report on Form 10-K for the year ended December 31, 2018, 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.

 

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