Norwegian government sponsored trial shows infliximab biosimilar is not inferior to continued treatment with Remicade, the originator drug.-Pfizer + Celltrion + Orion + Mundipharma
New data presented at the 2016 United European Gastroenterology (UEG) Week show that a switch to biosimilar infliximab (CT-P13)(Inflectra) 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.
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. 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, 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.
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.
Related news and insights
Medtronic’s newest generation self-expanding, transcatheter aortic valve replacement (TAVR) system, Evolut FX, significantly improved commissure alignment during TAVR procedures compared to earlier generation Evolut systems. A late breaker presentation at PCR London Valves 2022 summarized the early limited market release experience with the Evolut FX system in 168 patients from six US centers
Anavex Life Sciences Corp. announced positive topline results from its Phase IIb/III ANAVEX2-73-AD-004 clinical trial of oral ANAVEX2 73 (blarcamesine) for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD).
Vaxxinity announced today that its next generation UB 612 COVID-19 vaccine, when administered as a single heterologous booster dose, elicited strong neutralizing antibodies against SARS-CoV-2 when compared head-to-head to three globally authorized platform vaccines administered as homologous boosters, confirming success in meeting the primary and key secondary immunogenicity endpoints of its pivotal global Phase III trial.