Celltrion announced on Sept. 15 that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 4 clinical trial to secure evidence supporting the high-dose 240 mg administration of Zymfentra (U.S. brand name for Remsima SC; active ingredient: infliximab).
Zymfentra is a subcutaneous (SC) formulation of infliximab developed by Celltrion. Unlike conventional infliximab, which is administered intravenously (IV) at hospitals, Zymfentra was developed to allow patients to administer the treatment through subcutaneous injection. In the United States, it is approved for the treatment of inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis.
The launch of the trial is part of Celltrion’s mid- to long-term growth strategy to diversify Zymfentra’s prescribing base in the U.S. autoimmune disease market and further differentiate the product’s competitiveness.
The U.S. clinical trial will be conducted at 55 institutions across the country, enrolling a total of 447 patients with Crohn’s disease (CD) and ulcerative colitis (UC).
Specifically, the trial aims to demonstrate non-inferiority between a high-dose intravenous (IV) formulation of infliximab and Zymfentra 240 mg, with the goal of securing objective clinical data needed to support future high-dose administration of Zymfentra.
Celltrion plans to proactively secure objective and reliable clinical data required for high-dose Zymfentra administration through the trial. The company expects this to expand dosing options and provide optimal treatment alternatives tailored to patients’ conditions and disease severity.
The trial is being pursued to adapt the personalized prescribing strategy of Remsima SC, which has been validated in the European market, to the U.S. market environment and maximize the product’s competitiveness.
Remsima SC recorded a market share of approximately 32% in the five major European markets (EU5) as of the first quarter of this year, maintaining steady growth. In Europe, a high-dose prescribing strategy tailored to patients’ disease severity has helped drive rapid market-share expansion.
Through the U.S. Phase 4 trial, Celltrion plans to secure data supporting the 240 mg high dose and establish a personalized two-track dosing system in the United States alongside the existing 120 mg dose.
In addition to diversifying dosing options, Celltrion is also pursuing indication expansion to maximize Zymfentra’s potential market size. The company is conducting global clinical development activities aimed at adding rheumatoid arthritis (RA) as a new indication and expanding the potential patient population for Zymfentra.
Celltrion’s strategy is to further strengthen the exclusive position of Zymfentra, the world’s only subcutaneous (SC) formulation of infliximab, by securing clinical evidence supporting high-dose administration.
