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Original Article
- Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease
- Ryohei Nomaru, Teruyuki Takeda, Atsushi Takahashi, Hiroyuki Mikumo, Shigeyoshi Yasukawa, Akihiro Koga, Takao Kanemitsu, Yoichiro Ono, Noritaka Takatsu, Masaki Miyaoka, Takashi Hisabe, Hisatomi Arima, So Imakiire, Eri Yamauchi, Shinya Ashizuka, Fumihito Hirai
- Received June 30, 2025 Accepted September 4, 2025 Published online November 27, 2025
- DOI: https://doi.org/10.5217/ir.2025.00118 [Epub ahead of print]
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Abstract
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Supplementary Material
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ePub - Background/Aims
The introduction of anti-tumor necrosis factor-α antibodies transformed the landscape of inflammatory bowel disease (IBD) treatment. Because biologics are associated with increased medical costs, the use of biosimilars (BS) is recommended. However, high-quality evidence on the efficacy of BS in Japan remains limited. Therefore, this study aimed to evaluate the efficacy and safety of BS in patients with IBD.
Methods
Patients with IBD who underwent a non-medical switch (NMS) from infliximab originator (IFX-O) to IFX-BS at Fukuoka University Chikushi Hospital were prospectively evaluated. The observation period was up to 56 weeks after the NMS, and the rate of continuation, clinical remission at 56 weeks, safety, and changes in trough concentration were analyzed. Moreover, a questionnaire survey regarding BS and NMS was conducted.
Results
A total of 167 patients were included in this study. The continuation rate for IFX-BS therapy after NMS was high (95.6%). The remission maintenance rate at 56 weeks was 85.7% for patients with Crohn’s disease and 77.8% for patients with ulcerative colitis. Adverse events were observed in 22.8% of patients. However, only 2 severe adverse events were recorded. The ratios of trough concentrations at 8, 24, and 56 weeks to that at week 0 were 115.6%, 101.2%, and 123.5%, respectively, indicating statistical non-inferiority. In a questionnaire survey, only 6.2% of the patients were aware of BS, however, more than half of them agreed with the NMS recommendation.
Conclusions
The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.
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Reviews
- IBD
- Korean clinical practice guidelines on biologics for moderate to severe Crohn’s disease
- Seong-Joon Koh, Sung Noh Hong, Soo-Kyung Park, Byong Duk Ye, Kyeong Ok Kim, Jeong Eun Shin, Yong Sik Yoon, Hong Sub Lee, Sung Hoon Jung, Miyoung Choi, Soo-Young Na, Chang Hwan Choi, Joo Sung Kim, on behalf of the IBD Research Group of the Korean Association for the Study of Intestinal Diseases
- Intest Res 2023;21(1):43-60. Published online October 18, 2022
- DOI: https://doi.org/10.5217/ir.2022.00029
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Abstract
PDFPubReaderePub
- Crohn’s disease (CD) is a relapsing and progressive condition characterized by diarrhea, abdominal pain, weight loss, and hematochezia that results in serious complications such as perforations, fistulas, and abscesses. Various medications, interventions, and surgical treatments have been used to treat CD. The Korean guidelines for CD management were distributed in 2012 and revised in 2017 by the Inflammatory Bowel Disease (IBD) Research Group of the Korean Association for the Study of Intestinal Diseases. Substantial progress in mucosal immunologic research has elucidated the pathophysiology of IBD, leading to development of biological agents for treatment of CD. The first developed biologic agent, tumor necrosis factor-α agents, were shown to be efficacious in CD, heralding a new era in management of CD. Subsequently, vedolizumab, a monoclonal antibody against integrin α4β7, and ustekinumab, a human monoclonal antibody that inhibits the common p40 subunit of interleukin-12 and interleukin-23, were both approved for clinical use and are efficacious and safe for both induction and maintenance of remission in moderate-to-severe CD patients. Moreover, a recent study showed the non-inferiority of CT-P13, an infliximab biosimilar, compared with infliximab in CD patients. The third Korean guidelines for CD management provide updated information regarding treatment of moderate-to-severe CD patients with biologic agents.
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Citations
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- 14,104 View
- 568 Download
- 43 Web of Science
- 41 Crossref
- Inflammatory bowel diseases
- Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases
- Sang Hyoung Park, Jae Cheol Park, Milan Lukas, Martin Kolar, Edward V. Loftus, Jr
- Intest Res 2020;18(1):34-44. Published online January 30, 2020
- DOI: https://doi.org/10.5217/ir.2019.09147
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Abstract
PDFPubReaderePub
- The inflammatory bowel diseases (IBD), which consist of Crohn’s disease and ulcerative colitis, are chronic, incurable immunemediated inflammatory disorders of the intestine. As IBD incidence continues to increase globally and its mortality is low, prevalent cases of IBD are rapidly increasing, thereby leading to a substantial increase in health care costs. Although the introduction of biologic agents for IBD management has revolutionized the armamentarium of IBD therapy, the high cost of this therapy is concerning. With the expirations of patents for existing biologic agents (originals), biosimilars with cheaper costs have been highlighted in the field of IBD. Despite concerns regarding their short- and long-term efficacy, safety, immunogenicity, and interchangeability, increasing evidence via prospective observations and phase III or IV clinical trials, which aim to prove the “biosimilarity” of biosimilars to originals, has partly confirmed their efficacy, safety, and interchangeability. Additionally, although patients and physicians are reluctant to use biosimilars, a positive budget impact has been reported owing to their use in different countries. In the near future, multiple biosimilars with lower costs, and efficacy and safety profile similar to originals, could be used to treat IBD; thus, further consideration and knowledge dissemination are warranted in this new era of biosimilars.
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Citations
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Maria I. Timanovskaia, Oleg V. Knyzev, Asfold I. Parfenov
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Jiyoung Yoon, Seung Wook Hong, Kyung-Do Han, Seung-Woo Lee, Cheol Min Shin, Young Soo Park, Nayoung Kim, Dong Ho Lee, Joo Sung Kim, Hyuk Yoon
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- Results of non-medical switching from original infliximab to its Russian biosimilar in patients with ulcerative colitis
- 10,084 View
- 223 Download
- 23 Web of Science
- 22 Crossref
Original Articles
- Inflammatory bowel diseases
- Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice
- Tomoo Nakagawa, Taku Kobayashi, Kiyohiro Nishikawa, Fumika Yamada, Satoshi Asai, Yukinori Sameshima, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
- Intest Res 2019;17(4):504-515. Published online August 23, 2019
- DOI: https://doi.org/10.5217/ir.2019.00030
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Abstract
PDFPubReaderePub
- Background/Aims
An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.
Methods
Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.
Results
Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.
Conclusions
In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease. -
Citations
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Tsubasa Oike, Naoki Akizue, Yuki Ohta, Hirotaka Koseki, Masaya Saito, Yuya Yokoyama, Yushi Imai, Takashi Taida, Kenichiro Okimoto, Keiko Saito, Sadahisa Ogasawara, Tomoaki Matsumura, Tomoo Nakagawa, Makoto Arai, Tatsuro Katsuno, Yoshihiro Fukuda, Yoshio K
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Gary R. Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G. Feagan
Expert Opinion on Biological Therapy.2024; 24(7): 691. CrossRef - Clinical experience of using biosimilars in Crohn’s disease and their effectiveness
Léa Sequier, Bénédicte Caron, Silvio Danese, Laurent Peyrin-Biroulet
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Eun Soo Kim, Sung Kook Kim, Dong Il Park, Hyo Jong Kim, Yoo Jin Lee, Ja Seol Koo, Eun Sun Kim, Hyuk Yoon, Ji Hyun Lee, Ji Won Kim, Sung Jae Shin, Hyung Wook Kim, Hyun-Soo Kim, Young Sook Park, You Sun Kim, Tae Oh Kim, Jun Lee, Chang Hwan Choi, Dong Soo Ha
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Tomoe Kazama, Katsuyoshi Ando, Nobuhiro Ueno, Mikihiro Fujiya, Takahiro Ito, Atsuo Maemoto, Keisuke Ishigami, Masanori Nojima, Hiroshi Nakase, Shintaro Sagami
PLOS ONE.2023; 18(9): e0288393. CrossRef - Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka, Toshifumi Hibi
Drug Safety.2023; 46(10): 991. CrossRef - Real-world safety and efficacy of CT-P13, an infliximab biosimilar, in Japanese rheumatoid arthritis patients naïve to or switched from biologics
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Shiro Ohshima, Makoto Inoue, Yutaka Yoshioka, Hisashi Yamanaka
Modern Rheumatology.2022; 32(4): 718. CrossRef - Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)
Bincy Abraham, Bertus Eksteen, Khan Nedd, Hrishikesh Kale, Dipen Patel, Jennifer Stephens, Ahmed Shelbaya, Richard Chambers, Arif Soonasra
Advances in Therapy.2022; 39(5): 2109. CrossRef - Safety, efficacy, and drug survival of the infliximab biosimilar CT‐P13 in post‐marketing surveillance of Japanese patients with psoriasis
Akimichi Morita, Kiyohiro Nishikawa, Fumika Yamada, Keiichi Yamanaka, Hideki Nakajima, Mamitaro Ohtsuki
The Journal of Dermatology.2022; 49(10): 957. CrossRef - Post‐marketing analysis for biosimilar CT‐P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan
Shintaro Sagami, Kiyohiro Nishikawa, Fumika Yamada, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2091. CrossRef - Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future
Brian Godman, Mainul Haque, Santosh Kumar, Salequl Islam, Jaykaran Charan, Farhana Akter, Amanj Kurdi, Eleonora Allocati, Muhammed Abu Bakar, Sagir Abdur Rahim, Nusrat Sultana, Farzana Deeba, M. A. Halim Khan, A. B. M Muksudul Alam, Iffat Jahan, Zubair Ma
Current Medical Research and Opinion.2021; 37(9): 1529. CrossRef - Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness
Jae Hee Cheon, Seongsu Nah, Hyoun Woo Kang, Yun Jeong Lim, Sang-Hoon Lee, Sang Joon Lee, Sung Hyun Kim, Na Hyun Jung, Jeong Eun Park, Yeo Jin Lee, Da Bee Jeon, Yeon Mi Lee, Jong Min Kim, Sung-Hwan Park
Advances in Therapy.2021; 38(8): 4366. CrossRef - The Great Debate With IBD Biosimilars
Jimmy K Limdi, Francis A Farraye
Crohn's & Colitis 360.2021;[Epub] CrossRef - Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
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Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning, Rita L. Hui
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Sang Joon Lee, KyungMin Baek, Sujin Lee, Yoon Jee Lee, Jeong Eun Park, Seul Gi Lee
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Current Gastroenterology Reports.2020;[Epub] CrossRef
- Efficacy and safety of biosimilar infliximab in bio-naïve patients with Crohn’s disease
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- WITHDRAWN:Knowledge and viewpoints on biosimilar monoclonal antibodies from members of the Asian Organization of Crohn’s and Colitis: comparison with European Crohn’s and Colitis members
- Soo-Kyung Park, Tadakazu Hisamatsu, Zhihua Ran, Shu-Chen Wei, Dong Il Park
- Received June 12, 2018 Accepted October 6, 2018 Published online November 12, 2018
- DOI: https://doi.org/10.5217/ir.2018.00084
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Citations
Citations to this article as recorded by- Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan
Muna Oqal, Bushra Hijazi, Abdelrahim Alqudah, Ahmad Al-Smadi, Basima A Almomani, Roaa Alnajjar, Majd Abu Ghunaim, Mohammad Irshaid, Aroob Husam, Gergely Feher
International Journal of Clinical Practice.2022;[Epub] CrossRef
- Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan
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- IBD
- Efficacy and safety of the adalimumab biosimilar Exemptia as induction therapy in moderate-to-severe ulcerative colitis
- Vandana Midha, Ramit Mahajan, Varun Mehta, Vikram Narang, Arshdeep Singh, Kirandeep Kaur, Ajit Sood
- Intest Res 2018;16(1):83-89. Published online January 18, 2018
- DOI: https://doi.org/10.5217/ir.2018.16.1.83
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Abstract
PDFPubReaderePub
<b>Background/Aims</b><br/> Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited.
Methods Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score.
Results A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years) with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis.
Conclusions The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.
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Citations
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Review
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- Dong Il Park
- Intest Res 2016;14(1):15-20. Published online January 26, 2016
- DOI: https://doi.org/10.5217/ir.2016.14.1.15
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Abstract
PDFPubReaderePub
Introduction of biological therapies have led to dramatic changes in the management of debilitating immune-mediated inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn's disease. However, the long term use of these agents may be very expensive, placing a significant burden on National Healthcare Systems. The development of first biosimilar to infliximab, CT-P13 (Remsima; Celltrion Inc., Incheon, Korea and Inflextra; Hospiral, Lake Forest, Illinois, USA) has become another way to decrease the medical care cost and increase patient treatment option, but, actual equivalence of efficacy and safety of CT-P13 was investigated in rheumatic diseases only. The extrapolation of outcome from rheumatic trials to IBD and the interchangeability of CT-P13 with infliximab have come to be a matter of concern. Two recent retrospective studies reported the similarity of CT-P13 in terms of efficacy and safety. Infliximab biosimilars may be promising new treatment options for IBD patients, however, well-designed, prospective randomized non-inferiority trials should be needed to confidently integrate infliximab biosimilars into IBD treatment.
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