Remsima in New Injection Form Shows Safety and Efficacy in Trial

Remsima in New Injection Form Shows Safety and Efficacy in Trial
A new formulation of CT-P13, a biosimilar of Remicade (infliximab), given as an under-the-skin injection is as safe and effective for people with active Crohn’s disease (CD) and ulcerative colitis (UC) as its approved intravenous version, known as Remsima, clinical trial data show. Switching from intravenous (into-the-vein, IV) Remsima to this under-the-skin (subcutaneous, SC) formulation was also seen to be safe in patients. Celltrion Healthcare, which developed both forms, is planning to request U.S. Food and Drug Administration approval for its SC version later this year, the company said in a press release. “The 1-year results including switching results show a comparable efficacy and safety profile between CT-P13 SC and IV,” professor Shomron Ben-Horin, MD, with Chaim Sheba Medical Center in Israel and a principal researcher for the Phase 1 trial, said in the release. “These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options,” he added. Remicade, by Janssen Immunology, is a synthetic antibody engineered to block the signals of the pro-inflammatory  tumor necrosis factor alpha (TNFα) molecule, which is a key driver of inflammation in inflammatory bowel disease (IBD). The therapy is approved for a number of autoimmune disorders, including IBD, but is costly. Celltrion developed CT-P13 as a biosimilar to Remicade, meaning it holds similar safety and efficacy profiles but is less costly. Remsima, this treatment given as a slow IV infusion, is approved across some 110 countries, including Europe and the U.S. A subcutaneous injection form would be more convenient, and potentially an at-home therapy. The open-label Phase 1 trial (NCT02883452)
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