| [ Summary ] |
Anti-tumor necrosis factor (TNF) antibody has become one of the treatment strategies for ulcerative colitis in addition to Crohn's disease. In recent years, extensive efforts have been made to produce biosimilar medications. Unlike generic medications, however, it is difficult to manufacture biologics identical to the preceding ones, owing to the complexities of the biotechnological process. Thus, intensified clinical trials are needed for the approval of biosimilars. Even after approval, automatic generic substitution and switching are not allowed for any biosimilar. CT-P13, a biosimilar of the anti-TNF infliximab, is the only biosimilar available in Japan. It has been confirmed in various cohort studies that CT-P13 has an efficacy and safety equivalent to infliximab in Korean and European patients with ulcerative colitis. Thus, it seems inevitable to accumulate data of biologics for the treatment of Japanese patients with inflammatory bowel diseases. |