Remicade Can Be Substituted for Less Expensive Biosimilar CT-P13, Clinical Trial Suggests

Remicade Can Be Substituted for Less Expensive Biosimilar CT-P13, Clinical Trial Suggests

Patients taking Remicade (infliximab) can safely switch to treatment with biosimilar CT-P13, sold as Pfizer’s Inflectra and Celltrion Healthcare’s Remsima, according to recently published results of a clinical study.

Results of the clinical trial were published with the title “Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial” in the journal The Lancet.

Inflammatory diseases such as psoriasis, rheumatoid arthritis (RA), and inflammatory bowel disease (IBD) include treatment with Remicade, an inhibitor of the inflammatory pathway TNF-alpha. But Remicade can be expensive, leading researchers to investigate whether switching to the less expensive CT-P13, a biosimilar, could be a viable option.

“In 2014, CT-P13 was recommended by Norwegian Health Authorities for patients starting treatment with [Remicade],” researchers wrote. “The cost saving for CT-P13 was 39% in 2014 compared with originator [Remicade], and increased to 69% after the 2015 tender. Thus, the introduction of biosimilar drugs could reduce financial burdens on health-care budgets. Additionally, biosimilars could improve overall and earlier access to these drugs in many countries with prescription restrictions based on their high cost.”

The Phase 4 NOR-SWITCH study (NCT02148640) enrolled 482 patients with inflammatory diseases taking Remicade. They were assigned to continue their treatment with Remicade or switch to CT-P13 (241 patients in each arm). Patients were followed up for 52 weeks.

The objective of the trial was to compare the effectiveness, safety, and the ability to regulate the immune system of Remicade compared to CT-P13. The trial’s primary endpoint was disease worsening during follow-up.

In the study, 30 (6%) had psoriatic arthritis; 35 (7%) had chronic plaque psoriasis; 155 patients (32%) had Crohn’s disease; 93 (19%) had ulcerative colitis; 91 (19%) had spondyloarthritis; and 77 (16%) had RA.

In the Remicade group, 53 patients (26.2%) experienced disease worsening, compared to 61 patients (29.6%) in the CT-P13 group, showing that both treatments had similar responses. The difference was not considered significant.

Also, Remicade and CT-P13 had similar safety profiles. In the Remicade group, nine patients (4%) discontinued treatment due to adverse events, compared to eight (3%) in the CT-P13 group.

“NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13,” Tore Kvien, the trial’s lead researcher, said in a news release.

“As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.”

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Joana brings more than 8 years of academic research and experience as well as Scientific writing and editing to her role as a Science and Research writer. She also served as a Postdoctoral Researcher at the Center for Neuroscience and Cell Biology in Coimbra, Portugal, where she also received her PhD in Health Science and Technologies, with a specialty in Molecular and Cellular Biology.

One comment

  1. Georgejjl says:

    Prurisol, an oral pill taken every 12 hours, Phase 2b trial currently enrolling might be an option soon.

    A Phase 2b trial has begun 4Q16 evaluating higher dosing regimens (300 mg and 400mg) in moderate-to-severe psoriasis, using proportion of subjects achieving PASI75 at Week 12 as the primary endpoint

    Below from a previous trial with the highest dose of just 200 mg/day.

    Among patients with the severest form of psoriasis in study, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46% of patients who received 200 mg per day. These data were derived from analyses of all patients.

    Good luck and GOD bless,


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