Celltrion said Monday that Health Canada has approved an additional indication for the company’s autoimmune disease treatment Remsima SC (infliximab) -- Zymfentra in the U.S. -- for inflammatory bowel disease (IBD).

IBD is a chronic, incurable intestinal disease in which the immune system targets the large or small intestine, causing multiple ulcers, bleeding, diarrhea, and abdominal pain. It has an estimated global treatment market of about $25.56 billion (33.28 trillion won) this year, according to the Business Research Company, a market researcher.

The new IBD indication approval is based on a global phase 3 study that included 343 people with Crohn's disease (CD) and 438 people with ulcerative colitis (UC). The study demonstrated statistically superior efficacy and similar safety to placebo for the primary endpoints of clinical remission (CD and UC) and endoscopic response rate (CD), as well as all key secondary endpoints, Celltrion said.

Remsima SC is the only biologic approved for subcutaneous (SC) injection of infliximab that is adapted from its traditional intravenous (IV) formulation to a subcutaneous (SC) formulation. In addition to significantly improving the convenience of treatment by allowing patients to inject the drug at their location without visiting a hospital, it has also shown promise in the clinic by demonstrating advantages over the existing IV formulation.

According to a post hoc analysis of the global phase 3 study of Remsima SC presented by Celltrion at an international meeting, Remsima SC was effective in restoring efficacy at the escalated dose (240 mg) compared to the original dose (120 mg), with no significant difference in safety. In addition, Remsima SC alone achieved similar levels of efficacy and safety compared to the immunosuppressant combination.

Based on these strengths, the market share of Remisma SC in five major European countries -- Germany, the United Kingdom, France, Italy, and Spain -- was about 20 percent as of the third quarter of last year, with a steep rise to 37 percent in Germany and 26 percent in France. Together with the original Remsima in IV formulation, the market share of infliximab in the five major European countries is about 72 percent.

In Canada, the vast land size of the country relative to the population is expected to increase patient convenience with self-administration. Celltrion Canada plans to leverage its extensive prescribing data from Europe and elsewhere to spread the word and position Remsima SC as a leading treatment for IBD.

In addition, Celltrion plans to accelerate its expansion into the North American market by securing IBD indications in Canada and launching Zymfentra as a new drug in the U.S. this year. In particular, the company has established a direct sales system to maximize profitability in the U.S. and Canada.

"The approval of additional IBD indications in Canada will accelerate our expansion into North America," a Celltrion official said. "Based on the efficacy and safety proven in global clinical trials, we will do our best to supply quality biopharmaceuticals in North America following our successful market share expansion in Europe."

Celltrion said it would continue to focus on development and investment to expand its biosimilar portfolio to 11 products by 2025, in addition to the six already commercialized. By 2030, Celltrion plans to have 22 products to reach its goal of 12 trillion won in annual sales.