Celltrion Publishes Data on Maintenance Therapy Using Infliximab Biobetter

Celltrion Healthcare shared positive phase 3 safety and efficacy data regarding its infliximab biobetter, Remsima SC, as maintenance therapy in patients with inflammatory bowel disease (IBD) at the European Crohn’s and Colitis Organization congress.

The data come after the FDA accepted Celltrion’s biologics license application for Remsima SC in January 2023. Intravenous Remsima was approved by the FDA in April 2016 and launched on the US market in November 2016, where it is marketed as Inflectra through a commercialization agreement with Pfizer. It is 1 of 4 infliximab biosimilars approved in the United States.

“We believe that CT-P13 SC, if approved in the U.S., has the potential to become the next-generation innovative therapeutic for IBD given its favorable clinical results and convenient subcutaneous route of administration,” commented Kevin Byoung Seo Choi, senior vice president and head of marketing division at Celltrion Healthcare.

Biobetters are a class of follow-on biologic products that are intentionally altered to improve clinical effects, allow for more time in between doses, or enhance tolerability. Although many biobetters are developed as alterations to originator biologics, Remsima SC is unique in that it is a biobetter based on a biosimilar of Remicade (reference infliximab). Remsima SC (CT-P13) is the world first subcutaneous infliximab product, which can be a more convenient method of administration for patients than intravenous injection.

IBD is an umbrella term for Crohn disease (CD) and ulcerative colitis (UC). The LIBERTY-CD and LIBERTY-UC trials were randomized, placebo-controlled, double-blind analyses that measured Remsima SC (CT-P13 SC) through 54 weeks. In total, 343 patients with IBD were randomized to receive the biobetter or placebo.

In the CD study, at week 54, the clinical remission rate was greater in the biobetter arm than the placebo arm (62.3% vs 32.1%, respectively; P < .0001). In the UC analysis, 438 patients were randomized to either treatment arm. At week 54, the rate of clinical remission was also significantly greater in the biobetter arm than the placebo arm (43.2% vs 20.8%, respectively; P < .001). The safety profile was comparable between treatment arms in both studies.

“These latest findings add to the growing body of evidence that supports the SC formulation of infliximab as a convenient and effective solution for treating IBD….These results demonstrate that maintenance therapy with CT-P13 SC provides a robust clinical benefit, with the convenience of SC administration, for patients with moderately to severely active CD and UC,” presenting author Jean-Frédéric Colombel, MD, director of the Inflammatory Bowel Disease Center at the Icahn School of Medicine at Mount Sinai, said in a statement.

The new data are an update to older data from the phase 3 LIBERTY trial that were shared at the European Congress of Rheumatology’s annual meeting in June 2022.