TY - JOUR
T1 - Evolution of infliximab biosimilar in inflammatory bowel disease
T2 - from intravenous to subcutaneous CT-P13
AU - Parigi, Tommaso Lorenzo
AU - D'Amico, Ferdinando
AU - Peyrin-Biroulet, Laurent
AU - Danese, Silvio
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
U2 - 10.1080/14712598.2020.1811849
DO - 10.1080/14712598.2020.1811849
M3 - Article
C2 - 32799561
VL - 21
SP - 37
EP - 46
JO - Expert Opinion on Biological Therapy
JF - Expert Opinion on Biological Therapy
SN - 1471-2598
IS - 1
ER -