Patients taking Remicade (infliximab) can safely switch to its biosimilar drug Inflectra (CT-P13), according to results from the NOR-SWITCH study, presented at UEG (United European Gastroenterology) Week 2016, in Vienna, Austria.
NOR-SWITCH (NCT02148640) is a Phase 4, randomized, double-blind trial designed to evaluate the safety and effectiveness of switching from Remicade to Inflectra in patients with chronic plaque psoriasis, ulcerative colitis, Crohn’s disease, rheumatoid arthritis, spondyloarthritis and psoriatic arthritis.
The study involved 481 patients from 40 locations who were on stable treatment with Remicade for at least six months. From October 2014 to July 2016, patients were randomly separated into two groups, one to continue on Remicade and one to switch to Inflectra, and then monitored for 52 weeks.
The primary goal of the study was to measure disease worsening, which was observed in 26.2% of the patients who remained on Remicade and in 29.6% of those patients who switched to Inflectra. The difference is not enough to consider that Inflectra is inferior to Remicade, so the biosimilar proved its non-inferiority as well, in addition to its safety.
The occurrence rates of disease worsening were generally similar across all indications included in the trial. Likewise, adverse reactions were comparable.
“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 press 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 receive this life-changing medicine,” he said.
Inflectra (developed by Celltrion) was the first biosimilar monoclonal antibody ever approved.
It was first approved in September 2013 by the European Medicines Agency (EMA) as Remsima and in April this year by the U.S. Food and Drug Administration (FDA) as Inflectra. Today, the biosimiliar is approved in more than 75 countries and is expected to become available in the U.S. this year.
“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,” said Man Hoon Kim, Celltrion’s president and chief executive officer. “We are proud that our biosimilar may enable more people with chronic inflammatory conditions to benefit from infliximab.”