Switch to Biosimilar Inflectra from Remicade Supported by Report at 2016 UEG Week

Switch to Biosimilar Inflectra from Remicade Supported by Report at 2016 UEG Week
Phase 4 trial results were recently presented that supported switching patients from Remicade (infliximab) to its biosimilar drug Inflectra as a safe and non-inferior alternative. The results, presented at the UEG (United European Gasroenterology) Week 2016 in Vienna, Austria, came from the NOR-SWITCH study in adult patients who had been switched to Inflectra treatment for 52 weeks for many conditions. NOR-SWITCH (NCT02148640) was a randomized, double-blind, Phase 4 clinical trial to evaluate the safety and effectiveness of switching from Remicade to Inflectra in patients with ulcerative colitis, Crohn's disease, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, and chronic plaque psoriasis. All 481 participants had been on Remicade for at least six months before they were switched to the biosimilar. In April, the U.S. Food and Drug Administration (FDA) approved Inflectra (a biosimilar of infliximab, developed by Celltrion) for all the same indications as Remicade (developed by Janssen). The drug is an FDA-approved biosimilar monoclonal antibody (mAb). It was approved by the European Medicines Agency in 2013 as Remsima. Inflectra is currently approved in more than 75 countries. “We conducted this study to assess how switching to biosimilar infliximab affects patients who are stable on the originator biologic,” Jørgen Jahnsen, MD, PhD, professor of gastroenterology at the University of Oslo, said in a news release. “The data shows that safety and efficacy are maintained post-switch and should give confidence to physicians looking to move their patients onto biosimilar infliximab for non-medical reasons such as cost. I am hopeful that switching will lead to financial savings that can in turn enable more patients to r
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