Celltrion presents data showing clinical benefit of its biosimilar infliximab

Korean biopharma company Celltrion Healthcare has presented data on the clinical experience of patients using its biosimilar infliximab (Johnson & Johnson's Remicade brand), showing its treatment is comparable to the reference product in terms of safety and efficacy.

Jørgen Jahnsen, a professor of gastroenterology at the University of Oslo, Norway, presented clinical data on his own experience of treating irritable bowel disease patients with biosimilar infliximab. The clinical data from 46 Crohn’s disease and 32 ulcerative colitis patients presented at the Digestive Diseases Week 2015 in Washington DC, showed a statistically-significant reduction in disease at week 14. Of those, eight ulcerative colitis and 14 Crohn’s patients were previously treated with other biologics. Among the Crohn’s disease patients, 76% were in clinical remission at week 14 after three infusions of biosimilar infliximab, with significant reductions in calprotectin and CRP. In ulcerative colitis, 56% were in clinical remission at week 14.

Prof Jahnsen said: “Following approval of the first biosimilar monoclonal antibody by the FDA [Food and Drug Administration], there is excitement and anticipation for biosimilar infliximab to also be approved in the US. In Norway, our experience of biosimilar infliximab in patients with IBD over the past year shows that the safety and efficacy of the treatment is comparable to that of the reference medicine, while offering potential budget savings. We therefore expect that the availability of biosimilar infliximab could contribute to improving patient access to advanced biologic treatments.”