Rheumatologists Expect More Extensive Clinical Trials for Biosimilars than Gastroenterologists, According to a New Report from BioTrends Research Group
September 30, 2013 - Exton, Penn.
– BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds that the majority of surveyed gastroenterologists do not expect to prescribe an infliximab biosimilar, such as Celltrion’s Remsima, in their Crohn’s disease (CD) or ulcerative colitis (UC) patients that has not been clinically tested in inflammatory bowl diseases.
The Biosimilars Advisory Service report entitled Physician Perspectives on Pegylated IFN-α and TNF-α Inhibitors in Immune and Infectious Disease
provides analysis of survey results from over 90 gastroenterologists, as well as more than 90 rheumatologists in the United States and Europe. The report finds that over 70 percent of surveyed gastroenterologists would not use biosimilar infliximab in CD or UC patients if the clinical trial had only been conducted in rheumatoid arthritis patients. Only a minority of survey respondents believe that indication extrapolation is an overall good idea.
The report also finds that surveyed rheumatologists are similarly cautious about indication extrapolation, but most biosimilars of TNF-alpha inhibitors under development are being studied in rheumatoid arthritis patients. This strategy by biosimilar manufacturers could help to alleviate rheumatologists’ concerns about prescribing these biosimilar TNF-alpha inhibitors, but this study also reveals that rheumatologists would prefer a longer treatment duration and more patients to be included in biosimilar clinical trials compared with their gastroenterology counterparts.
“The concept of indication extrapolation is particularly relevant to prescribers of TNF-alpha inhibitors because of the breadth of indications that these biologics are used in,” said Biosimilars Research Director Kate Keeping. “The first biosimilar TNF-alpha inhibitor that gastroenterologists will have access to, Celltrion/Hospira’s Inflectra (infliximab), has not been clinically tested in CD or UC patients, which will likely limit uptake in these patients, at least until direct clinical evidence is available.”
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