Celltrion recently confirmed that it proved the effectiveness of its subcutaneous infliximab biosimilar, RemsimaSC (CT-P13 SC) in two global Phase III trials. The Phase III study was a 54-week study conducted on 438 patients of ulcerative colitis and 343 Crohn’s disease patients. According to Celltrion “[t]he results showed that RemsimaSC demonstrated significantly high efficacy than the placebo group. In terms of safety, the treatment did not show a meaningful difference from the placebo group.”
As we previously reported, Celltrion obtained approval for RemsimaSC in Europe in 2018. Based on the positive results of the recent Phase III trials, Celltrion has stated that it plans to apply for U.S. FDA approval within the year.
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