Biosimilar Inflectra Matches Remicade as Crohn’s Treatment, Trial Results Show

Biosimilar Inflectra Matches Remicade as Crohn’s Treatment, Trial Results Show
The biosimilar therapy Inflectra (infliximab CT-P13) is as good a treatment as Remicade (infliximab) for those with moderate-to-severe Crohn’s disease (CD), according to the results of a clinical trial. Pfizer and Celltrion Healthcare, which developed Inflectra, presented the results at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO). Two hundred fourteen patients with Crohn's participated in the randomized, double-blind, parallel-group, 54-week Phase 3 clinical trial (NCT02096861). It was designed to assess whether Inflectra was as effective and safe as Remicade, developed by Janssen Immunology. Biosimilars are close copies of original therapies, but cheaper. Those making the ECCO presentation indicated that the trial met its primary goal of Inflectra performing as well as Remicade against Crohn's. The trial assessed the proportion of patients who had a decrease of 70 points or more in the Crohn’s Disease Activity Index (CDAI-70) after six weeks. The response rates were not statistically significantly different between those treated with Inflectra (71.4 percent) and Remicade (75.2 percent). Other measures of disease activity, such as remission and CDAI-1oo response rates, were also similar. In addition, Inflectra's safety and tolerability profile was similar to Remicade's in the trial. No safety
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