EDT Gastroenterologists Unlikely To Use Celltrion/Hospira’s Infliximab Biosimilar Due To Lack Of Clinical Data In Inflammatory Bowel Disease Rheumatologists Expect More Extensive Clinical Trials for Biosimilars than Gastroenterologists, According to a New Report from BioTrends Research Group EXTON, Penn., Sept. 30, 2013 /PRNewswire via COMTEX/ — 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-a and TNF-a 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.” The Biosimilars Advisory Service provides insight and analysis that is vital to successful business planning in the rapidly evolving biosimilars space. The service includes quarterly webinars detailing major developments, analyst insight addressing key market changes and opportunities, therapeutic area-specific primary research and forecasting modules. About BioTrends Research GroupBioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please visit http://www.bio-trends.com . BioTrends is a Decision Resources Group company.
Study: Certain Gastroenterologists Likely to Skimp on Biopsy Samples
Unfortunately, not all physicians follow these guidelines, and a new study points to one possible reason. The study , performed by U.S.-based clinicians and published by the European Journal of Gastroenterology & Hepatology, used a large national database to identify all adults who had endoscopies and biopsies for celiac disease between 2006 and 2009. The researchers then analyzed those cases, which involved more than 92,000 people, to determine whether gastroenterologists who performed more endoscopies than the average tended to take fewer samples of the intestinal lining during each procedure. As it turned out, gastroenterologists with a higher procedure volume — in other words, who performed lots of endoscopies — did take fewer intestinal samples. Meanwhile, the study also found that gastroenterologists who worked more closely with other members of their medical specialty tended to take more samples, possibly because of peer-to-peer education. The authors note that most cases of celiac remain undiagnosed in the U.S., in part because too few physicians follow the guidelines calling for at least four samples of the intestinal lining. The moral of this story? If you’re undergoing celiac disease testing , try to choose a gastroenterologist who doesn’t perform tons of endoscopies, or one who works in concert with other gastroenterologists. And, stress during your pre-procedure visit that you expect the gastroenterologist to take at least four samples of your small intestine. Keep up with the latest in the celiac disease/gluten sensitivity world — sign up for my newsletter , connect with me on Facebook and Google+ , or follow me on Twitter – @AboutGlutenFree . Photo Getty Images/Rob Melnychuk