what do rheumatologists think?

>82% >75% 96% U.S. rheumatologists welcome the availability of biosimilars but are overwhelmingly concerned about the FDA’s approval process, in particular, interchangeability and naming issues. These are the findings of a survey recently conducted by the Coalition of State Rheumatology Organizations (CSRO), a nationwide group of state and regional professional rheumatology societies. The survey sought the perceptions of this specialist physician group towards biosimilars and their potential impact on patients. More than 82 percent of respondents believe that the FDA’s standards for designating a biosimilar as "interchangeable" must be very rigorous to ensure patient Over 75 percent of respondents said the FDA should mandate that biosimilars have a different non-proprietary name than the innovator biologic medicine While almost 96 percent of rheumatologists surveyed said the FDA should require labeling to identify a medication as a biosimilar and distinguish any important differences between it and the reference drug. • A clearly distinguishable non-proprietary name for the biosimilar to remove the potential for confusion with the reference product, and ensure that both physician and patient are appropriately informed about the medication being dispensed • The label for a biosimilar must include the non-proprietary name and any differences in safety or efficacy data unique to the biosimilar • The need to clinically test biosimilars for each condition for which the reference product is In light of these survey results, CSRO announced a number of policy recommendations for the approval of biosimilars that include: Read More: http://bit.ly/1CoMKey Source:The Coalition of State Rheumatology Organizations. Survey Of Rheumatologists Nationwide Regarding Biosimilars Highlights Need For More Robust FDA Standards. PR Newswire. 2015. Available at: http://www.prnewswire.com/news-releases/survey-of-rheumatologists-nationwide-regarding- biosimilars-highlights-need-for-more-robust-fda-standards-300107924.html Accessed July 5, 2015. biolink.us

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>82%

>75%

96%

U.S. rheumatologists welcome the availability of biosimilars but are overwhelmingly concerned about the FDA’s approval process, in particular, interchangeability and naming issues.

These are the findings of a survey recently conducted by the Coalition of State Rheumatology Organizations (CSRO), a nationwide group of state and regional professional rheumatology societies.

The survey sought the perceptions of this specialist physician group towards biosimilars and their potential impact on patients.

More than 82 percent of respondents believe that the FDA’s standards for designating a biosimilar as "interchangeable" must be very rigorous to ensure patient

Over 75 percent of respondents said the FDA should mandate that biosimilars have a different non-proprietary name than the innovator biologic medicine

While almost 96 percent of rheumatologists surveyed said the FDA should require labeling to identify a medication as a biosimilar and distinguish any important differences between it and the reference drug.

• A clearly distinguishable non-proprietary name for the biosimilar to remove the potential for confusion with the reference product, and ensure that both physician and patient are appropriately informed about the medication being dispensed

• The label for a biosimilar must include the non-proprietary name and any differences in safety or efficacy data unique to the biosimilar

• The need to clinically test biosimilars for each condition for which the reference product is

In light of these survey results, CSRO announced a number of policy recommendations for the approval of biosimilars that include: