Please see the resources below to learn more about the issues surrounding the use of biosimilars.
November 9, 2016
Meaningful suffixes are important in medicine. That’s why 80% of doctors prefer them for biosimilar naming as well. The FDA is considering naming biosimilar medicines with a random code versus a more recognizable name. In a recent SERMO* poll, representing over 500 physicians across multiple specialties, 80% of physicians prefer a “meaningful suffix.” Physician groups across the country call for biosimilar names that are easily distinguished and recognized. *SERMO is the largest global social network exclusively for doctors. Read More ›
July 29, 2015
The American Gastroenterological Association (AGA) released the findings of a national survey of gastroenterologists on biologics and biosimilars. The survey of 180 AGA members examined their prescribing practices and explored their views on the safety and quality standards needed as biosimilars enter the U.S. marketplace. Specifically, 40 percent of respondents felt they were extremely or very familiar with biosimilars while 51 percent were somewhat or slightly familiar with biosimilars. Additionally, 67 percent of respondents favored a policy whereby the FDA would not allow indication extrapolation in the approval of biosimilars for inflammatory bowel diseases relative to a policy that allowed for indication extrapolation. Read More ›
July 1, 2015
The Coalition of State Rheumatology Organizations (CSRO), released findings of a national survey of rheumatologists that explored perceptions of biosimilar medicines. They survey revealed rheumatologists have concerns about the biosimilars approval process and overwhelmingly support clearer regulatory standards for these new therapies. Specifically, 75 percent of rheumatologists surveyed say the FDA should mandate that biosimilars have a different non-proprietary name than the innovator biologic medicine and more than 82 percent of respondents believe that the FDA approval standards for designating a biosimilar as "interchangeable" must be very rigorous to ensure patient safety. Read More ›