Expert opinion on biological therapy · 2020
Evolution of infliximab biosimilar in inflammatory bowel disease: from intravenous to subcutaneous CT-P13.
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Parigi Tommaso Lorenzo, D'Amico Ferdinando, Peyrin-Biroulet Laurent, Danese Silvio
Аннотация
INTRODUCTION: Biologic drugs have significantly improved the treatment of ulcerative colitis (UC) and Crohn's disease (CD). However, the availability of these drugs is limited by their high cost. Infliximab was the first biologic to be approved for inflammatory bowel diseases (IBD). After its patent expired other manufactures developed biosimilar versions, among which CT-P13, and licensed them thorough an expedite process.
AREAS COVERED: The aim of this review is to summarize the available evidence on CT-P13 use in IBD, with particular interest in the phase II trials of a subcutaneous version of CT-P13.
EXPERT OPINION: Biosimilars, such as CT-P13, are an important resource for health-care systems. Although CT-P13 approval in IBD was based on extrapolation, subsequent studies confirmed its clinical equivalence to originator infliximab. A new subcutaneous formulation of CT-P13 showed promising results in phase I and II trials in both CD and UC. Clinical efficacy and safety were comparable and interestingly serum drug doses appeared to be more stable than conventional intravenous CT-P13. If these preliminary results will be confirmed, the first sub-cutaneous version of infliximab could soon be available for IBD.
AREAS COVERED: The aim of this review is to summarize the available evidence on CT-P13 use in IBD, with particular interest in the phase II trials of a subcutaneous version of CT-P13.
EXPERT OPINION: Biosimilars, such as CT-P13, are an important resource for health-care systems. Although CT-P13 approval in IBD was based on extrapolation, subsequent studies confirmed its clinical equivalence to originator infliximab. A new subcutaneous formulation of CT-P13 showed promising results in phase I and II trials in both CD and UC. Clinical efficacy and safety were comparable and interestingly serum drug doses appeared to be more stable than conventional intravenous CT-P13. If these preliminary results will be confirmed, the first sub-cutaneous version of infliximab could soon be available for IBD.