Celltrion

• Switching from intravenous (IV) to subcutaneous (SC) infliximab was shown to be well tolerated, with a low relapse risk for most IBD patients and high treatment persistence^{1, 2}

INCHEON, South Korea – Celltrion, Inc. today showcased real-world evidence supporting the use of subcutaneous (SC) infliximab, confirming the efficacy and safety of switching to SC infliximab 120mg every two weeks in patients with inflammatory bowel disease (IBD).

The real-world evidence was presented at the Meet the Expert (MTE) Sessions at UEG 2025, and included presentations from Professor Nicolas Mathieu, Medical Director of MICI Institut Privé, Cliniques des Cèdres and Associate Professor of Gastroenterology, and Prof Anthony Buisson, Head of IBD Unit at University Hospital Estaing, Clermont Ferrand, France.

Professor Nicolas Mathieu presented a real-life study which demonstrated that the switch from IV infliximab to SC infliximab is well tolerated amongst patients. The presentation particularly highlighted the results from the multicentric, prospective PEREM real-life cohort study, which found high treatment persistence, with more than 95% of patients in remission remaining on therapy after one year in real-world practice.¹ In addition, there was no significant difference of SC infliximab persistence at Week 48 between patients who were on combination therapy with immunomodulator at both inclusion and 3 months and those on SC infliximab monotherapy.²

In Professor Anthony Buisson’s session, it was shared that patients switching from IV to SC infliximab is feasible and safe, even in challenging cases such as obesity, prior perianal disease, or patients with complicated phenotypes (structuring or fistulizing CD). Long term persistence of SC infliximab was also confirmed in multiple studies across the UK and France, and was generally considered effective, safe, and well accepted, with low relapse risk in most IBD patients. SC infliximab also showed promising efficacy after IV induction in patients with active perianal lesions.¹

“The Meet the Expert sessions provide an important opportunity to share real-world evidence on the role of subcutaneous infliximab,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The evidence confirms that switching from intravenous to subcutaneous therapy is effective and safe and supports more sustainable healthcare delivery.”

Notes to Editors:

About the subcutaneous (SC) formulation of CT-P13

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.^3,4 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-IV induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.⁵ Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.⁶

About Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines.

For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

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References

¹ Buisson A et al. Clinical Gastroenterology and Hepatology 2023; Buisson A et al. Alimentary Pharmacology and Therapeutics 2023
² Mathieu N et al., Persistence and Safety of Subcutaneous Infliximab 1 Year After Switch From Intravenous Route in IBD Patients in REMission. Clinical Gastroenterology and Hepatology. 2025
³ Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353
⁴ Westhovens R et al., Rheumatology. 2021;60(5):2277-2287
⁵ European Medicines Agency Summary of Product Characteristics (SmPC), Remsima®. Available at link to SmPC [Last accessed October 2025].
⁶ Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060