Injection Form of Remicade Biosimilar for IBD Similar to Approved Infusion, Phase 1 Trial Shows

Injection Form of Remicade Biosimilar for IBD Similar to Approved Infusion, Phase 1 Trial Shows
A new formulation of CT-P13, a biosimilar of Remicade (infliximab), that is given as an under-the-skin (subcutaneous) injection, was shown to be as safe and effective in treating inflammatory bowel disease (IBD) as its first and approved intravenous infusion version. CT-P13 IV (intravenous infliximab) is sold under the brand names Remsima and Inflectra. The subcutaneous version, should it be approved, is applicable for home use and self-administration. Results from a Phase 1 trial (NCT02883452) showed that the new subcutaneous (SC) formulation of CT-P13 could ease disease activity and induce remission in people with ulcerative colitis and Crohn’s disease at similar rates to those treated by its IV form. Trial findings were detailed in the study “Noninferiority of Novel Subcutaneous Infliximab (CT-P13) to Intravenous Infliximab (CT-P13) in Patients with Active Crohn's Disease and Ulcerative Colitis: Week 30 Results from a Multicentre, Randomised Controlled Pivotal Trial,” presented at the United European Gastroenterology (UEG) Week 2019 in Barcelona. A Phase 3 trial (NCT03945019) is now recruiting 600 people with moderately to severely active Crohn's disease to further test CT-P13 SC, this time to show superiority against placebo. Rates of clinical remission after one year of treatment is this trial's primary and sole goal. Enrollment information, possibly at a single Cincinnati, Ohio, site, is available here. Remicade, by Janssen Immunology, is a synthetic antibody engineered to block the signals of the tumor necrosis factor alpha (TNFα) molecule, which are known to be important drivers of inflammation. It is approved to treat a number of autoimmune disorders, including IBD, but is costly. Celltrion Healthcare  developed CT-P13 as a biosi
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