A recent nationwide survey of rheumatologists has revealed their concerns over the biosimilars approval process and their support of clear regulatory standards for these drugs.

1. >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.
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