Celltrion said Monday it proved the effectiveness and safety of RemsimaSC (pipeline name: CT-P13 SC), an autoimmune disease treatment, in two global phase 3 trials.  

RemsimaSC is a subcutaneous injection (SC) form of infliximab, widely used in TNF-α inhibitor market. It is the world’s first infliximab SC form, displaying immediate injection effect.  

Celltrion has conducted phase 3 studies for patients with ulcerative colitis and Crohn’s disease, respectively, to release RemsimaSC as a new drug in the U.S.

The company divided 438 patients with ulcerative colitis and 343 patients with Crohn’s disease into RemsimaSC and placebo groups and conducted the global studies for 54 weeks. 

The 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. 

Based on the results, the company plans to apply for U.S. FDA approval within the year.

Celltrion scored marketing approval for RemsimaSC from European Medicines Agency (EMA) in November 2019 and achieved an infliximab market share of 27 percent in Germany and 16 percent in France in the second quarter, according to the company. 

“We will do our best to have RemsimaSC settle in the U.S. market early by emphasizing fast administration effect and convenient formulation,” an official said.