Biosimilar Demonstrates Non-Inferiority to Remicade

Article

Study found no statistically significant differences when switching from biologic to biosimilar.

New study results demonstrate no statistically significant difference in the worsening of autoimmune disease when switching from infliximab (Remicade) to the biosimilar Inflectra.

NOR-SWITCH, was a randomized, double-blind, parallel group study that was funded by the Norwegian government.

The randomized, controlled trial is the first to compare the impact of switching to Inflectra from infliximab. The findings further support prior clinical trial results and add to the growing body of evidence that supports the biosimilar switch.

For the study, published in The Lancet, investigators sought to examine the safety, efficacy, and immunogenicity of switching from the originator infliximab to the cheaper biosimilar.

Included in the study were 482 adult patients who were randomized to either continue treatment with infliximab or switch to Inflectra, with unchanged dosing regimen. Data were collected at infusion visits in 40 Norwegian study centers.

The primary endpoint was worsening disease during 52-week follow-up, according to the study.

Disease states were Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis.

The results of the study showed that in the infliximab originator arm, disease worsening occurred in 53 patients compared with 61 patients in the Inflectra arm. The frequency of adverse events was found to be similar among the groups.

“The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 [Inflectra] was not inferior to continued treatment with infliximab originator according to a prespecified non-inferiority margin of 15%,” the authors wrote. “The study was not powered to show non-inferiority in individual diseases.

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