Celltrion has reconfirmed the safety and competitiveness of its subcutaneous formulation autoimmune disease treatment Remsima SC with the latest clinical research data.

Celltrion announced on the 25th that it will present the latest clinical results for “Remsima SC (ingredient: infliximab)” in Korea for the first time at the 2026 Asian Organization for Crohn’s and Colitis and the International Meeting of the Korean Association for the Study of Intestinal Diseases (AOCC 2026 in conjunction with IMKASID 2026), held in Seoul. The company stated that the 44-week Phase 3 results from Japan once again demonstrated its global competitiveness and product strength, based on data showing excellent therapeutic efficacy and safety.

In Japan, only the intravenous (IV) formulation of Celltrion’s Remsima is currently marketed. The IV formulation alone holds a 44% market share in Japan. Once Remsima SC, whose product strength has been verified in major markets such as the United States and Europe, is launched in Japan, it is expected to generate strong synergy with the existing Remsima.

The announcement covers research results that drew significant attention when they were unveiled at Digestive Disease Week (DDW) 2026 in the United States. It is an encore domestic presentation of Phase 3 clinical results from a study in 60 Japanese patients with Crohn’s disease (CD). The trial evaluated efficacy and safety over 44 weeks after switching patients who had achieved clinical remission with the existing IV formulation of Remsima to the subcutaneous (SC) formulation, Remsima SC. According to the clinical results, patients switched to the SC formulation maintained clinical remission and endoscopic remission indices stably during the 44-week maintenance treatment period. No safety concerns were identified.

At this conference, Celltrion Pharm, an affiliate of the Celltrion Group, is operating a large independent booth to conduct extensive academic marketing. The company expects synergies by leveraging real-world prescription data on Remsima SC from overseas healthcare professionals.

In addition, during the conference period Celltrion is holding a luncheon symposium. Professor Hong Sung-no of Samsung Medical Center, a global key opinion leader (KOL) in the field of inflammatory bowel disease, and Professor Silvio Danese of San Raffaele University in Italy will serve as speakers. They will share the latest insights on topics including “Personalizing IBD Treatment: The Role of Therapeutic Drug Monitoring in Infliximab Therapy” and “Real-World Experience with Subcutaneous Infliximab: Updated Global Evidence.” Celltrion expects that as clinical data on Remsima SC continue to be presented at major global conferences, confidence in and preference for prescribing the product will further increase. In practice, such clinical data are driving an expansion of prescriptions in global markets.

As of the fourth quarter of last year, Remsima SC held a 31% market share in the five major European countries (EU5). In addition, in the United States, the world’s largest market, prescription volume in the first quarter of this year is reported to have increased more than threefold year-on-year. The product is assessed to be solidifying its position in the global autoimmune disease therapeutics market.

A Celltrion official stated, “By presenting the latest clinical results for Remsima SC, the company has once again reinforced confidence in its competitiveness and in the product,” adding, “Celltrion will continue to secure clinical evidence in global markets to accelerate prescription expansion and ensure that patients can benefit from treatment.”

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