Celltrion once again demonstrated the competitiveness of its Remsima SC at the 2024 European Crohn's and Colitis Organization (ECCO) congress in Stockholm, Sweden, from last Wednesday to Saturday by receiving favorable reviews from overseas medical professionals.

At the ECCO, attended by more than 8,000 medical professionals worldwide, Celltrion was the only Korean company that ran an exclusive promotional booth and conducted various marketing activities, including expert seminars.

Professor Flavio Caprioli from the University of Milan, Italy, introduced the competitiveness of Remsima SC at a seminar entitled "Italian Experience with Infliximab SC: Real World Data." The seminar highlighted the recent focus on endoscopic remission in inflammatory bowel disease (IBD), achieved in 92 percent of the 43 patients who switched from IV infliximab to Remsima SC.

Professor Caprioli emphasized that all hard-to-treat colon sites were responsive, with transmural remissions occurring as barrier thickness gradually improved.

Professor Milan Lukas from Charles University, Czech Republic, followed with a seminar titled "Infliximab CT-P13 SC in Clinical Trials and Real Clinical Practice". The study analyzed 32 patients with refractory Crohn's disease who had failed two or more biologics and found that after 12 months of treatment with infliximab CT-P13 SC, the Harvey- Bradshaw Index (HBI), a measure of disease activity, improved as the drug concentration in the blood increased after switching to infliximab CT-P13 SC.

In addition, data from 74 patients who switched from IV infliximab or adalimumab to Remsima SC showed that 93 percent of patients achieved treatment persistence with Remsima SC, with drug levels remaining above the therapeutic IBD level of 5 ug/mL.

Celltrion also presented the first results from the two-year (102-week) long-term follow-up of the global phase 3 clinical trial of Remsima SC during a poster session last Friday. The study included 180 patients with Crohn's disease and 237 patients with ulcerative colitis who had been receiving Remsima SC maintenance treatment for approximately one year and extended treatment to week 102 to confirm the long-term efficacy and safety of Remsima SC. Clinical results showed similar efficacy results at week 102 as at week 54 (one year), with no new safety concerns identified.

In addition, Celltrion held a symposium with the theme of "Achieving Endoscopic Healing with Subcutaneous Infliximab for Inflammatory Bowel Disease: A Path to Improving Long-term Outcomes," presenting the latest IBD treatment trends and data from the Remsima SC study.

The company drew the attention of medical professionals by explaining the concept and significance of endoscopic healing, which has recently been recommended by major regulatory agencies such as the EMA and FDA, and presented global post-hoc analysis results and real-world data confirming the efficacy of mucosal healing with Remsima SC.

Through the conference, Celltrion unveiled multiple clinical trials and real-world prescribing data demonstrating the efficacy and safety of Remsima SC, raising expectations for the success of Zympentra (the U.S. name for RAMSIMA SC), which is expected to launch in the U.S. in the first quarter of this year. Zymfentra (Remsima SC’s U.S. name), which was approved as a new drug by the U.S. FDA in October last year, is considered to be well-positioned for success in the U.S. market due to its ability to command a higher selling price than existing biosimilars and patent protection up to 2040.

"At this year's ECCO, we presented many RemsimaSC studies that demonstrated patient convenience as well as therapeutic efficacy and safety and received great interest and response from physicians in attendance," a Celltrion official said. "As we expect prescribing preference for Remsima SC to increase, we are committed to bringing the therapeutic benefits of infliximab SC formulations to more patients in the U.S. through the upcoming launch of Zymfentra and Europe."