Biosimilar of costly inflammatory bowel disease therapy found safe and effective

Treatment of Crohn's disease and ulcerative colitis has been greatly improved by the introduction of biologic therapies such as infliximab (which targets tumour necrosis factor alpha), but at considerable cost. A recent analysis of results from 11 published studies including 829 patients shows that a new and lower-cost biosimilar for infliximab—called CT-P13 (Remsima/Inflectra)—has excellent clinical efficacy and safety.

Biosimilars are highly similar versions of complex biologic therapies. CT-P13 has been recently approved in the United States, the European Union, Australia, Canada, Japan, and many other countries.

"Meta-analyses of the efficacy among these studies showed that induction of clinical response in Crohn's disease and ulcerative colitis was achieved in over 70% of patients at short (8-14 weeks) and medium (24-30 weeks) terms," said Dr. Atsushi Sakurab, senior author of the Alimentary Pharmacology & Therapeutics analysis.

"Analysis of safety also showed that adverse effects related to CP-T13 were rare," said lead author Dr. Yuga Komaki. "Furthermore, the pooled rates of sustained clinical responses after switching from infliximab to CT-P13 remained high at 75% to 96% through a period of 1 year."

The authors noted that the results of their comprehensive analysis will help guide physicians to confidently and safely initiate or transition patients to CP-T13.