Celltrion announced on the 19th that it has received additional approval from Health Canada for the autoimmune disease treatment Remsima SC (generic name infliximab) for the indication of inflammatory bowel disease.
The infliximab ingredient is used to treat various autoimmune diseases including inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, and psoriasis. In Canada, Remsima SC was approved in 2021 only for rheumatoid arthritis, but with this additional approval, its indication has expanded to include inflammatory bowel disease. Inflammatory bowel diseases such as Crohn's disease and ulcerative colitis are chronic intractable intestinal diseases in which the immune system attacks the colon or small intestine, causing multiple ulcers, bleeding, diarrhea, and abdominal pain. The global market research firm The Business Research Company estimates that the global market size for inflammatory bowel disease will reach $25.56 billion (approximately 34 trillion KRW) this year.
This expansion of the inflammatory bowel disease indication was based on a global Phase 3 clinical trial conducted on 343 Crohn's disease patients and 438 ulcerative colitis patients. This was the clinical trial Celltrion previously conducted to obtain new drug approval for Remsima SC in the United States. Celltrion plans to launch Jimptetra (the U.S. brand name for Remsima SC) as a new drug in the U.S. market on the 29th.
In the clinical trial, Remsima SC demonstrated statistically superior efficacy and comparable safety to placebo in all primary endpoints, including clinical remission and endoscopic response rate (Crohn's disease), as well as all major secondary endpoints.
Remsima SC is the only subcutaneous injection drug among infliximab treatments, which were previously available only as intravenous infusions. It greatly improves treatment convenience by allowing patients to self-inject at their preferred location without visiting a hospital, and clinical trials showed advantages compared to the existing intravenous formulation. According to a post-analysis of the global Phase 3 trial of Remsima SC presented by Celltrion at an international conference, Remsima SC showed effectiveness in regaining efficacy with dose escalation (240 mg) compared to the standard dose (120 mg) without significant differences in safety. Additionally, the Remsima SC monotherapy group secured similar levels of efficacy and safety compared to the group receiving combination therapy with immunosuppressants.
Based on these strengths, Remsima SC already holds about a 20% market share as of the third quarter of last year in the five major European countries, where all indications for infliximab have been obtained. In particular, when combined with the existing intravenous formulation Remsima, the market share reaches approximately 72%.
The company expects that, given Canada's geographic characteristics with a large territory relative to its population, the increased patient convenience from self-administration will have a significant effect. Celltrion's Canadian branch plans to promote the product's excellence based on accumulated prescription data from Europe and establish Remsima SC as a leading treatment in the field of inflammatory bowel disease. Furthermore, since a direct sales system has been established to maximize profitability in both the U.S. and Canada, synergy is also expected from the new drug launch of Jimptetra in the U.S. this month.
A Celltrion representative said, “With the additional approval for inflammatory bowel disease indication in Canada, we can accelerate our North American market penetration for Remsima SC. Based on the efficacy and safety proven in global clinical trials, we will do our best to supply high-quality biopharmaceuticals in North America following the successful market share expansion in Europe.”
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