'3 Days Until US Launch' Celltrion's Remsima SC Reaffirms Product Competitiveness at Global Conference

Published 26 Feb.2024 09:22(KST)

Celltrion's autoimmune disease treatment, RemsimaSC (active ingredient infliximab), once again demonstrated its product competitiveness and received high praise from overseas medical professionals at the '2024 European Crohn's and Colitis Organisation (ECCO)' held in Stockholm, Sweden from the 21st to 24th (local time).

Professor Flavio Caprioli from the University of Milan, Italy, is presenting research results related to Celltrion's Remsima SC at the European Crohn's and Colitis Organisation (ECCO).
[Photo by Celltrion]

ECCO is a leading European inflammatory bowel disease conference attended annually by more than 8,000 medical experts. The latest clinical research and trends in therapeutic development related to these diseases are presented. Following last year, Celltrion was the only domestic company to open a standalone promotional booth this year as well, conducting various marketing activities including expert seminars.

First, Professor Flavio Caprioli from the University of Milan, Italy, introduced the competitiveness of RemsimaSC through a seminar titled "Infliximab SC Experience in Italy: Real-World Data." He emphasized that while treatment for inflammatory bowel disease traditionally focused on 'clinical remission,' which controls symptoms, recently, ‘endoscopic remission,’ meaning all ulcers are healed as seen endoscopically, has been gaining attention. Among 43 patients who switched from the conventional intravenous infliximab formulation to the subcutaneous RemsimaSC, 92% achieved this. He highlighted that effectiveness was observed in various difficult-to-treat colon areas, and as the thickness of the intestinal wall gradually improved, transmural remission of the intestinal wall was also observed.

Next, Professor Milan Lukas from Charles University in the Czech Republic conducted a seminar titled "Infliximab SC Confirmed in Clinical Research and Real-World Medical Practice." This study analyzed 32 refractory Crohn's disease patients who had no response to two or more biological agents and were treated with RemsimaSC for 12 months. After switching to RemsimaSC, as blood drug concentrations increased, treatment improvement was confirmed in disease activity indicators such as the Harvey-Bradshaw Index (HBI). Data analyzing 74 patients who switched from intravenous infliximab or adalimumab to RemsimaSC showed that 93% maintained treatment persistence with RemsimaSC, and drug concentrations in the body were maintained higher than the IBD treatment blood concentration of 5 μg/mL.

Professor Milan Lukas from Charles University in the Czech Republic gave a presentation on Remsima SC at the European Crohn's and Colitis Organisation (ECCO 2023) last year.
[Photo by Lee Chunhee]

Through the poster session, Celltrion also unveiled for the first time the two-year (102-week) long-term follow-up results of the global Phase 3 clinical trial of RemsimaSC. The study extended treatment up to week 102 in 180 Crohn's disease patients and 237 ulcerative colitis patients undergoing RemsimaSC maintenance therapy, confirming the long-term efficacy and safety of RemsimaSC. The clinical results showed that efficacy at week 102 was maintained at a level similar to that at one year (54 weeks), and no new safety concerns were identified.

Additionally, Celltrion introduced recent trends in inflammatory bowel disease treatment and RemsimaSC research data through a symposium titled "Endoscopic Treatment Achievement of Infliximab Subcutaneous Formulation for Inflammatory Bowel Disease: A Journey Toward Improved Long-Term Treatment Outcomes." The symposium explained the concept and significance of endoscopic treatment recently recommended by major regulatory agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). It also disclosed global post hoc analysis results and real-world data confirming mucosal healing efficacy with RemsimaSC administration, attracting attention from attending medical professionals.

The company explained that by releasing numerous data on the efficacy and safety of RemsimaSC at this conference, expectations are growing for the new drug Zimpenetra (the U.S. product name for RemsimaSC), which will be launched in the United States on the 29th. Zimpenetra was approved as a new drug by the FDA in October last year. This allows for a higher sales price compared to existing biosimilars and secures patent protection until 2040, laying the foundation for a successful U.S. market entry.

A Celltrion official stated, "At this year's ECCO, many research results proving the convenience for patients as well as the treatment efficacy and safety of RemsimaSC were disclosed, receiving great interest and positive responses from medical professionals attending the event. As prescription preference for RemsimaSC is expected to increase, we will do our best to ensure that more patients in the U.S., as well as Europe, can benefit from the infliximab SC formulation treatment through the upcoming launch of Zimpenetra."