Celltrion Inc reveals promising data for bowel disease treatment

Biopharmaceutical company Celltrion Healthcare, in the virtually held United European Gastroenterology (UEG) Week, from October 3-5, disclosed positive data related to using subcutaneous formulation of infliximab, CT-P13 (Remsima SC), treating patients suffering from inflammatory bowel disease (IBD).

For the uninitiated, CT-P13 was the first monoclonal antibody biosimilar which was approved by the European Commission (EC), under the trade name Remsima in September 2013 and launched in prominent EU countries in early 2015.

In the recent virtual summit, the presentation Celltrion showed that the first study examined the clinical impact of replacing intravenous (IV) treatment with subcutaneous (SC) treatment of infliximab in patients having ulcerative colitis (UC) or Crohn’s disease (CD) from the randomized controlled pivotal trial of CT-P13 SC.

Results indicated that replacing IV with SC infliximab presented more favorable clinical outcomes with regards to efficacy, pharmacokinetics and immunogenicity.

The second study revealed comparable efficacy of subcutaneous (SC) infliximab monotherapy as compared to combination therapy with immunomodulators with the help of data from the randomized controlled pivotal trial of CT-P13 SC in active CD or UC.

Director of Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna, Professor Walter Reinisch, mentioned that the analysis shows that replacing IV with SC infliximab will offer comparable clinical outcomes for patients with inflammatory bowel disease, along with those having Crohn's disease and ulcerative colitis. He further stated that Infliximab SC provides more convenient care with the potential for in-home use.

MD, Department of Gastroenterology, Chaim Sheba Medical Center in Israel, Professor Shomron Ben-Horin, stated that these exploratory results indicate that monotherapy of SC infliximab may give comparable outcomes and immunogenicity to combination therapy with immunomodulators, thus promoting SC infliximab monotherapy as a possible treatment option for IBD patients.

With these studies, Celltrion Healthcare has shown its commitment to providing innovative therapies as it continues to manufacturer its products at advanced mammalian cell culture facilities, designed and built to comply with the guidelines of US FDA cGMP and the EU GMP.

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