Plan to Submit FDA Approval Application Within the Year
[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 28th that it has proven both efficacy and safety in two global Phase 3 clinical trials conducted for the U.S. launch of its autoimmune disease treatment 'RemsimaSC'. Based on these clinical results, Celltrion plans to submit a marketing authorization application to the U.S. Food and Drug Administration (FDA) within this year.
RemsimaSC is a product developed as a subcutaneous (SC) formulation of infliximab, which is widely used in the 'TNF-α' (tumor necrosis factor) inhibitor market. During the approval consultation stage in the U.S., the formulation's distinctiveness was recognized, and the FDA recommended proceeding through the new drug approval process. Accordingly, Celltrion has conducted clinical trials of RemsimaSC targeting patients with ulcerative colitis and Crohn's disease, respectively.
In the global Phase 3 clinical trials conducted up to 54 weeks, 438 ulcerative colitis patients and 343 Crohn's disease patients were divided into RemsimaSC treatment groups and placebo control groups. RemsimaSC demonstrated statistically significantly higher efficacy compared to the placebo groups in both trials, proving its superiority, and showed no meaningful difference in safety compared to the placebo groups.
RemsimaSC is currently a product that has secured exclusive rights for about 20 years by completing patent applications for its formulation and administration method in approximately 130 countries. In Europe, it obtained marketing authorization from the European Medicines Agency (EMA) in November 2019 and is being sold through Celltrion Healthcare, which is responsible for overseas sales and marketing of Celltrion products.
As the world's first infliximab SC formulation, RemsimaSC boasts rapid dosing effects and formulation convenience, achieving a market share of 27% in Germany and 16% in France as of the second quarter of this year, recording a 10.7% share in the infliximab market across the five major European countries.
A Celltrion official stated, "RemsimaSC, which has rapidly grown after entering Europe first, has proven efficacy and safety in the global Phase 3 clinical trials conducted for entry into the U.S. market as a new drug, and we are now entering the final stage of the approval application." He added, "Based on the clinical results, we will proceed with the FDA approval application preparations without delay and do our best to establish an early foothold in the market by emphasizing the rapid dosing effect and formulation convenience."
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