Celltrion Healthcare recently presented positive clinical results of recent studies evaluating the efficacy and safety of switching from the original infliximab therapy (RMP) to the biosimilar infliximab Remsima® treatment in patients with inflammatory bowel disease (IBD). The results were presented at the United European Gastroenterology Week (UEG Week) 2015.
Biosimilar infliximab Remsima is a monoclonal antibody approved for the treatment of immune-mediated inflammatory diseases. It is the first biosimilar monoclonal antibody approved by the European Medicines Agency (EMA) for all the conditions that RMP is also approved for. Biosimilar drugs are a class of medicines designed to have the same active properties of a previously licensed drug, and one of the main advantages of these products is the reduced cost in comparison to the original drug.
In the first study, researchers evaluated the switch of therapies in 74 IBD patients (56 with Crohn’s disease and 18 with ulcerative colitis) who were in remission after long-term treatment with RMP. After a median follow-up of 24 weeks, treatment with Remsima proved to be effective, with maintenance of the remission state, and same profile of allergic reactions and minimal side effects when compared to RMP treatment. The clinical efficacy of Remsima was also tested in 93 anti-TNF naïve IBD patients (69 with Crohn’s disease and 24 with ulcerative colitis) with results showing that Remsima is comparable to RMP in terms of clinical efficacy and biological remission.
In another clinical trial, researchers evaluated 173 IBD patients (95 with Crohn’s disease and 51 with ulcerative colitis), with no previous therapy management or who had not been previously treated with RMP, and conducted a follow-up after 30 weeks. The study results, published in the journal Expert Review of Gastroenterology and Hepatology under the title “Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea,” confirmed the efficacy and tolerability of Remsima and the clinical equivalence of both drugs. Early clinical results, previously presented at the 2015 European Crohn’s and Colitis Organization annual meeting and described in other publications, further confirmed the efficacy and safety of Remsima in patients with both ulcerative colitis and Crohn’s disease.
Dr. Stanley Hong, President and CEO of Celltrion Healthcare commented on the results in a press release, “The new real-world experience with Remsima® in IBD adds to the expanding body of clinical evidence. Biosimilar infliximab can support greater and earlier access to biological therapies while reducing the financial burden on healthcare systems around the world. Switching to biosimilars offers comparable clinical benefits at a lower price, allowing medical communities to realize higher cost-savings. We are committed to ensuring as many IBD patients as possible benefit from this important therapy.”
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