Biosimilar infliximab safe and effective in IBD

Biosimilars/Research | Posted 16/06/2017 post-comment0 Post your comment

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].


Remsima/Inflectra (CT-P13) were approved by the European Medicines Agency (EMA) in September 2013 [1] and Inflectra (infliximab-dyyb) was approved by the US Food and Drug Administration (FDA) in April 2016 [2].

Atsushi Sakurab and colleagues from the University of Chicago Medicine, Northwestern University Feinberg and the School of Medical and Dental Sciences, Kagoshima, Japan, reviewed safety and efficacy data of biosimilar infliximab in patients with IBD. The group searched electronic databases and found 11 observational studies reporting outcomes in 829 patients treated with biosimilar infliximab (CT-P13).

Meta-analyses of the efficacy among these studies showed that induction of clinical response in Crohn’s disease and ulcerative colitis was achieved in over 70% of patients at short (8−14 weeks) and medium (24−30 weeks) terms. At 8−14 weeks pooled clinical response rates were 0.79 (95% CI, 0.65−0.88) among patients with Crohn’s disease (CD) and 0.74 [95% confidence interval (CI): 0.65−0.82) among patients with ulcerative colitis (UC). At 24−30 weeks the pooled clinical response rates were 0.77 (95% CI: 0.63−0.86) and 0.77 (95% CI: 0.67−0.85) for CD and UC, respectively.

Analysis of safety also showed that adverse effects related to CT-P13 were rare [CD, 0.08 (95% CI: 0.02−0.26); UC, 0.08 (95% CI: 0.03−0.17)].

Furthermore, the pooled rates of sustained clinical responses after switching from infliximab to CT-P13 remained high at 75% to 96% through a period of one year. The pooled rates of sustained clinical response among CD and UC patients after switching from infliximab to CT-P13 at 30−32 weeks were 0.85 (95% CI: 0.71−0.93) and 0.96 (95% CI: 0.58−1.00), respectively, and at 48−63 weeks were 0.75 (95% CI: 0.44−0.92) and 0.83 (95% CI: 0.19−0.99), respectively. Adverse events were also rare in patients that switched [CD, 0.10 (95% CI: 0.02−0.31; UC, 0.22 (95% CI: 0.04−0.63)].

The authors therefore concluded that ‘CT-P13, a biosimilar of infliximab, was effective and safe among IBD patients’. Although they admitted that ‘further studies are needed’, they added that ‘the results of our study support the use of CT-P13 in the treatment of IBD’.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
Readers interested to learn more about infliximab biosimilars are invited to visit to view the following manuscripts published in GaBI Journal:

The anti-TNF biosimilar CT-P13 had comparable efficacy to infliximab in rheumatoid arthritis over one year

Switching from the infliximab reference product to CT-P13 in patients with rheumatoid arthritis or ankylosing spondylitis: results of the PLANETAS and PLANETRA extension studies

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1. Komaki Y, Yamada A, Komaki F, Micic D, Ido A, Sakuraba A. Systematic review with meta-analysis: the efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017;45(8):1043-57.
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 16]. Available from:

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