Biosimilar of costly inflammatory bowel disease therapy found safe and effective

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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.

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