Safety and Efficacy of Biosimilar Infliximab Treatment in IBD Patients Presented at DDW 2015

Safety and Efficacy of Biosimilar Infliximab Treatment in IBD Patients Presented at DDW 2015

Celltrion Healthcare and Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo in Norway recently presented at the Digestive Diseases Week (DDW) 2015 in Washington D.C. results from a study that examined the effects of biosimilar infliximab in 78 patients with inflammatory bowel disease (IBD). The results showed that the treatment is as effective and safety as the reference medicinal product (RMP). During the satellite symposium, Jørgen Jahnsen, shared his clinical experience of treating patients with IBD in Norway with biosimilar infliximab.

During the meeting, results derived from the study were presented, which demonstrated that the treatment reduced disease activity after 14-weeks in 46 Crohn’s disease (CD) and 32 ulcerative colitis (UC) patients. From the total group of patients, 22 had been previously treated with other biologics.

“Following approval of the first biosimilar monoclonal antibody by the FDA, 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,” said Professor Jahnsen in a news release.

“It is exciting to see both the acceptance within the GI community, and the real-life benefits of biosimilar infliximab in Europe. Inflammatory bowel diseases are chronic disabling disorders that impact every aspect of a patient’s life and biosimilar infliximab is a new treatment option for patients with IBD,” said meeting chair Walter Reinisch, Professor of Gastroenterology, McMaster University, Canada.

During the symposium, other presentations were focused on biologics and biosimilars, with the speakers sharing their experiences with biosimilars and clarifying how extrapolation is intrinsic to biosimilarity and how interchangeability is now widely recognized.

The speakers also discussed the NOR-SWITCH study, a study that will be undertaken in 18 hospitals across Norway that aims to recruit 500 people to assess the safety and efficacy of switching from the RMP to biosimilar infliximab, Results are expected in 2016.

During the DDW 2015 there were two poster presentations regarding the efficacy and safety of biosimilar infliximab as treatment for patients with CD and UC. The titled were:

  • “Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. J Kierkus. Abstract Tu1081, Poster sessions Tuesday, May 19, 09:30-16.00 ET; Hall C.”
  • “Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. K. Gecse, et al. Abstract Tu1348, Poster sessions Tuesday, May 19, 09:30-16.00 ET; Hall C.”

The FDA is still reviewing Celltrion’s biologics license application for biosimilar infliximab.

“The data presented at our satellite symposium further builds the evidence base for the efficacy of biosimilar infliximab in people with IBD. Many countries including the US suffer from increasing healthcare cost and we believe that a cost-effective treatment option like biosimilars will help substantially decrease the burden. As we await the results of the FDA’s review of our application for the approval of biosimilar infliximab, we are happy to present real-world data at such an eminent global gastroenterology congress as DDW 2015,” said Dr Stanley Hong, President and CEO of Celltrion Healthcare in the news release.