[ THE INVESTOR ] South Korea‘s Celltrion has presented the primary outcome from its pivotal randomized controlled trial of CT-P13, a Remicade biosimilar which is branded as Remsima, in inflammatory bowel disease, the company said on Feb. 20.



These data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease is comparable to those treated with Remicade, the blockbuster drug from US Johnson & Johnson.











The result was presented at the 12th Congress of the European Crohn’s and Colitis Organization held in Barcelona, Spain.



The phase 3 trial in 220 patients with Crohn’s disease examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index, or CDAI, a measurement used to quantify the symptoms of Crohn’s disease patients.



According to the six-week data, similar clinical remission, CDAI-70 and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.



“While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of a randomized controlled trial and it’s encouraging to see such positive data from Celltrion’s trial,” Jørgen Jahnsen, professor of gastroenterology at the University of Oslo, Norway, said.



CT-P13 was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency and is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease.



It was approved by the EMA under the trade name Remsima in September 2013 and launched in Europe in early 2015. The US Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra.



By Park Han-na (hnpark@heraldcorp.com)