Rheumatologists and Gastroenterologists are Reluctant to Prescribe Biosimilars for Indications in Which They Have Not Been Clinically Tested

According to Biosimilars Advisory Service: Physician Perspectives on Biologics in Immunology & Infectious Disease, a similar proportion of surveyed rheumatologists and gastroenterologists, 49 percent and 47 percent, respectively, say that indication extrapolation should be performed carefully because some patients might be more sensitive to minute differences between the brand and the biosimilar. Despite the moderate uptake of biosimilars that we expect from these specialists, the sheer size of this market means that biosimilars for immune diseases will be the most lucrative class of biosimilars by 2021. Survey findings suggest that in order for gastroenterologists and rheumatologists to feel comfortable prescribing a biosimilar, a randomized, Phase III trial comparing the biosimilar to its reference brand would be required in all indications. This differs from regulatory guidance in the United States, Europe and Japan which states that indication extrapolation is permitted, as long as it is scientifically justified by the applicant. Surveyed gastroenterologists and rheumatologists are hesitant to adopt biosimilars unless these agents demonstrate robust clinical data, so incentives, like cost reduction, will be important to facilitate uptake, said Biosimilars Advisory Service Director, Andrew Merron, Ph.D. Despite the moderate uptake of biosimilars that we expect from these specialists, the sheer size of this market means that biosimilars for immune diseases will be the most lucrative class of biosimilars by 2021. The Physician Perspectives on Biologics in Immunology & Infectious Disease module of the Biosimilars Advisory Service offers extensive primary research with US, French and German gastroenterologists and rheumatologists to highlight the key expectations that will drive or constrain biosimilar adoption. Insights from surveyed gastroenterologists and rheumatologists provide a sound basis for annualized, brand-specific biosimilar sales forecasts for the TNF-alpha inhibitors, other major biologics used in immune diseases and pegylated interferon alpha products, which are all included in the module. Sales forecasts are provided through 2021 across the seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, the United Kingdom and Japan). About BioTrends Research Group BioTrends 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 contact us at (610) 321-9400 or http://www.bio-trends.com . BioTrends is a Decision Resources Group company. About Decision Resources Group Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at http://www.DecisionResourcesGroup.com . All company, brand, or product names contained in this document may be trademarks of their respective holders. Contacts

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Gastroenterologists Use New Technology to Detect Precancerous Cells

The WATS3Dcomputer-assisted brush biopsy takes a wide sample of tissue from the esophagus and then analyzes it using a 3-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. WATS3D stands for Wide Area Transepithelial Sample. URMC Gastroenterologist Vivek Kaul, M.D. , along with Gastroenterology Fellows Danielle Marino, M.D., and Donald Tsynman, M.D., today in Orlando, Fla., presented new research examining WATS3D at Digestive Disease Week, the worlds largest gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. WATS3D computer-assisted brush biopsy takes a wide sample of tissue from the esophagus. Our study examined patients who have had previous endoscopic therapy for dysplastic Barretts esophagus, a condition that can be a precursor to esophageal cancer, said Marino. In these high-risk patients, the goal is to confirm that all precancerous tissue has been eliminated, in order to prevent recurrence of dysplasia and cancer in the long term. Precancerous changes in patients with Barretts esophagus can be difficult to detect because they are often flat and patchy in distribution. The current standard of care for screening patients involves using multiple forceps biopsies to collect samples from the esophagus, but research has shown that this method is not always accurate or adequate. The WATS3D brush biopsy is designed to overcome the limitations of forceps biopsy by collecting a tissue sample from a wider area within the esophagus, thus potentially increasing the yield during surveillance tissue sampling. In three of the 11 patients included in our study, WATS3D found residual Barretts esophagus after endoscopic therapy that the forceps biopsies had missed, said Kaul, associate professor of Medicine and chief, Division of Gastroenterology and Hepatology at URMC. Weve been waiting for a new technology to help us address this important unmet need the results seen with WATS3D indicate a promising area for further research in the field of Barretts esophagus. A sample of abnormal cells detected with WATS3D. About Digestive Disease Week Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), this year DDW takes place May 18-21, 2013, at the Orange County Convention Center, Orlando, Fla. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

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