Specialty Pharma Journal Specialty, Precision & Technology
INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved HERZUMA® (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to HERCEPTIN®1 (trastuzumab) for the following indications: Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR …
Tag Archives: celltrion
December, 2018
November, 2018
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29 November
FDA Approves Celltrion’s Truxima, a Biosimilar to Rituxan, for Treatment of Adult Patients with Non-Hodgkin’s Lymphoma
INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA® (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN®1 (rituximab) for the treatment of adult patients in three indications: Relapsed or refractory, low-grade or follicular, CD20-positive, …
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19 November
Biosimilars Have the Potential to Deliver Dramatic Cost Savings for US and European Healthcare Systems
LONDON–(BUSINESS WIRE)–Celltrion Healthcare outlined their vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5th Annual Biosimilars USA Conference in New Jersey, US. Biosimilars offer healthcare providers and patients greater treatment choice and value, better access to treatments and improved patient outcomes. According to data provided by IMS …
September, 2018
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12 September
Celltrion Announces FDA Oncologic Drugs Advisory Committee Meeting Schedule for Proposed Biosimilar to Rituxan
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) today announced that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan®1 (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018. Rituxan® is a Biogen and …
August, 2018
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10 August
Celltrion Initiates Global Phase 3 Trial for its Bevacizumab Biosimilar CT-P16
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) is set to launch global Phase 3 clinical trial for its bevacizumab biosimilar ‘CT-P16’ for the treatment of cancer. Celltrion successfully completed Phase 1 clinical study on the safety and pharmacokinetic assessment of CT-P16 in June 2018. Further, it recently submitted its Clinical Trial Application …
June, 2018
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18 June
Celltrion Completes Resubmission to FDA for CT-P6, a Proposed Trastuzumab Biosimilar
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last …
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13 June
Celltrion Showcases Promising Preliminary Results for New Subcutaneous Formulation of CT-P13 in Rheumatoid Arthritis
AMSTERDAM–(BUSINESS WIRE)–New data presented at the Annual European Congress of Rheumatology (EULAR 2018) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with rheumatoid arthritis (RA) up to week 30. The …
May, 2018
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31 May
Celltrion Completes Resubmission for Biosimilar Candidate CT-P10 to FDA for Review
INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P10 (rituximab), a proposed mAb biosimilar to Rituxan®. Additionally, Celltrion plans on making a resubmission for the approval of CT-P6, a proposed biosimilar to Herceptin® in June. In accordance …
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23 May
Biosimilars Could Facilitate Early Access to Life Changing Biological Treatments for Patients
BALTIMORE–(BUSINESS WIRE)–At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. Several studies show that the early introduction of biologics can bring …
October, 2017
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30 October
One Year Maintenance and Switching Data in Patients with Crohn’s Disease Support the Use of Inflectra in IBD
NEW YORK–(BUSINESS WIRE)–New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period.1The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients …