4.3 Article

Pharmacokinetics, efficacy and safety of the rituximab biosimilar CT-P10

期刊

EXPERT REVIEW OF CLINICAL PHARMACOLOGY
卷 10, 期 9, 页码 923-933

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TAYLOR & FRANCIS LTD
DOI: 10.1080/17512433.2017.1359537

关键词

Biosimilar; chronic lymphocytic leukemia; CT-P10; efficacy; non-Hodgkin's lymphoma; rituximab; rheumatoid arthritis; safety

资金

  1. Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea

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Introduction: Rituximab, an anti-CD20 monoclonal antibody, is a key therapeutic in the treatment of B cell lymphomas and rheumatoid arthritis (RA). Global rates of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and RA are increasing, with a concomitant rise in individual and overall treatment costs. As such, biosimilar development may help facilitate greater access to treatment. The rituximab biosimilar CT-P10 (Truxima (R)) has recently received approval in Europe and South Korea for all indications held by reference rituximab (RTX). Areas covered: Here, the unmet needs and current market in the treatment of NHL, CLL and RA are outlined, followed by a comprehensive examination of the analytical, pre-clinical and clinical data demonstrating the equivalence and similarity of CT-P10 to RTX including with respect to pharmacokinetics, efficacy, safety and immunogenicity. Expert commentary: The rising treatment costs of NHL, CLL and RA pose a challenge to constrained healthcare budgets worldwide. Biosimilars may provide an effective solution to this conundrum. CT-P10 is equivalent to RTX in terms of efficacy and pharmacokinetics, and has a similar safety and immunogenicity profile. Approved in all indications held by RTX, CT-P10 has the potential to reduce treatment costs and thereby increase patient access to rituximab therapy.

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