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Survey: Gastroenterologists Unlikely to Use Infliximab Biosimilar
Docs cite lack of clinical data in inflammatory bowel disease (September 30)
BioTrends Research Group, a research and advisory firm located in Exton, Penn., finds that most of the surveyed gastroenterologists do not expect to use an infliximab biosimilar that has not been clinically tested in inflammatory bowel disease, such as Remsima (Celltrion), in patients with Crohn’s disease (CD) or ulcerative colitis (UC).
The new report analyzes survey results from more than 90 gastroenterologists and more than 90 rheumatologists in the U.S. and Europe.
The report finds that more than 70% of surveyed gastroenterologists would not use a biosimilar version of infliximab in CD or UC patients if the clinical trial had been conducted only in patients with rheumatoid arthritis (RA). Only a minority of survey respondents believed that indication extrapolation is a good idea.
The report also finds that surveyed rheumatologists are similarly cautious about indication extrapolation, but most biosimilars of tumor necrosis factor-alpha (TNF-alpha) inhibitors under development are being studied in RA patients. This strategy by biosimilar manufacturers could help to alleviate rheumatologists’ concerns about prescribing these biosimilar TNF-alpha inhibitors, but the new survey study also finds that rheumatologists would prefer longer treatment 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 analyst 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.”
Source: Decision Resources; September 30, 2013.