VIENNA — (BUSINESS WIRE) — New data presented at the 2016 United European Gastroenterology (UEG) Week show that a switch to biosimilar infliximab (CT-P13) from originator infliximab is not inferior to continued treatment with the originator and that patients can be safely switched.
The clinical study, sponsored by the Norwegian government, involved nearly 500 patients at 40 sites across Norway who had been on stable infliximab treatment for at least six months. The patients were living with chronic inflammatory diseases: Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis.
Approximately half of the patients were switched to Celltrion Healthcare’s biosimilar infliximab (CT-P13) and the findings show that efficacy and safety were comparable between this group and those who remained on the originator. They also indicate that the time to study drug discontinuation was almost identical between the two groups. 1 Further data presented at UEG Week on remission rates in Crohn’s disease and ulcerative colitis show that the remission rate with biosimilar infliximab (CT-P13) was comparable to the originator.
Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, and co-author of the NOR-SWITCH study, said: “We conducted this study to assess how switching to biosimilar infliximab affects patients who are stable on the originator biologic. 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 receive this life-changing medicine.”
Real-world Data in Support of Biosimilar Infliximab
The positive results of the NOR-SWITCH study build on a growing body of real-world data that support the safety and efficacy of biosimilar infliximab (CT-P13). A number of real-world studies were presented at UEG Week, 2,3,4,5,6,7,8 including a tertiary centre study of a cohort of anti-TNF naïve patients with inflammatory bowel disease (IBD) which concluded that both efficacy and safety of biosimilar infliximab (CT-P13) were comparable to that observed previously with originator infliximab.
An Italian study presented at a Celltrion Healthcare satellite symposium during the congress involving 547 IBD patients in 31 referral centres, concluded that biosimilar infliximab (CT-P13) is as safe and effective as the originator. There was no increase in infusion reactions or loss of response in patients who were switched to biosimilar infliximab (CT-P13) from the originator.
Cost-competitive Drugs Can Lead to Increased Access for Patients
Real-world cost savings associated with the use of biosimilar infliximab (CT-P13) were studied in five European countries: Germany, France, Italy, Spain and UK. According to new data presented at UEG Week, total cost savings in 2015 ranged from €1.35 million in Germany to €5.97 million in Spain. The Spanish findings suggest that use of biosimilar infliximab (CT-P13) could allow up to 1,085 extra patients per year to access biologic therapy. There were no cost savings in France, as the price of biosimilar infliximab (CT-P13) and originator were the same.
Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “Now more than ever, healthcare systems around the world are under pressure to reduce spending. I applaud the Norwegian government for this landmark study which will enable them to reduce healthcare costs in the confidence that patients switched to biosimilar infliximab will experience efficacy and safety comparable to the originator.”
“The NOR-SWITCH study builds on a wealth of data that support appropriate switching of patients to biosimilar infliximab, with new studies being presented all the time. At Celltrion Healthcare, we are proud that our biosimilar may enable more people with chronic inflammatory conditions to benefit from infliximab.”
Filed Under: Drug Discovery