Effectiveness, Safety of Remicade’s Biosimilar, Inflectra, Confirmed in Phase 3 Trial

Effectiveness, Safety of Remicade’s Biosimilar, Inflectra, Confirmed in Phase 3 Trial
Switching Crohn’s disease patients from Remicade (infliximab) to its biosimilar Inflectra has no negative impact to treatment safety or effectiveness, a Phase 3 clinical trial shows. Pfizer and Celltrion Healthcare jointly presented those trial results at the 25th United European Gastroenterology (UEG) Week, Barcelona, Spain. A biosimilar is a medicine highly similar to another, already approved, medicine (the "reference medicine"). In this case, Remicade is the reference medicine and Inflectra (infliximab-dyyb) – known in Europe as Inflectra (infliximab CT-P13) – is the biosimilar. The Phase 3 study (NCT02096861) was a randomized, double-blind, parallel-group trial that recruited 220 patients with active Crohn’s disease, set out to compare the overall safety and effectiveness between Inflectra and Remicade after one year (54 weeks) of treatment. The primary objective of the study was to determine Inflectra’s effectiveness using the Crohn’s disease Activity Index (CDAI)-70 response rates at six weeks of treatment. At that point, the data showed that Inflectra is as effective as Remicade in the treatment of Crohn’s disease. Then researchers evaluated patient outcomes after week 30, when patients were assigned randomly to either continue their course of treatment – either Remicade or Inflectra – or switch to the other therapy: Remicade patients switched to Inflectra, and those on Inflectra switched to Remicade. The results showed that treatment safe
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