CSRO survey reveals rheumatologists have concerns about biosimilars approval process

The Coalition of State Rheumatology Organizations (CSRO)Jul 2 2015

The Coalition of State Rheumatology Organizations (CSRO), a nationwide group of state and regional professional rheumatology societies, today released the findings of a national survey of rheumatologists that explored perceptions of biosimilars and the potential impact of these new drugs on patients.

Biosimilars are medicines that are highly similar, but not identical, to biologic medicines. They are notably different from generic medications in that it is impossible to exactly duplicate the structure and behavior of a biologic drug. The survey revealed rheumatologists have concerns about the biosimilars approval process and overwhelmingly support clearer regulatory standards for these new therapies, which are anticipated to result in cost savings.

"Rheumatologists nationwide welcome the development of biosimilars as an avenue for improving patient access to important biologic medications. However, we also want to ensure patient safety is at the forefront of the FDA's approval process as biosimilars come to market," said CSRO President Dr. Michael Schweitz. "This survey affirms that further guidance from FDA on critical issues such as interchangeability and naming are needed before additional biosimilars are approved."

Specific findings of the CSRO survey include:

• More than 82 percent of respondents believe that the U.S. Food and Drug Administration (FDA) approval standards for designating a biosimilar as "interchangeable" must be very rigorous to ensure patient safety;
• Over 75 percent of rheumatologists surveyed say the FDA should mandate that biosimilars have a different non-proprietary name than the innovator biologic medicine;
• Nearly 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 innovator biologic.

In response to the survey, CSRO also announced its policy recommendations for the approval of biosimilars, including:

• There should be a clearly distinguishable nonproprietary name for the biosimilar to ensure there is no confusion with the reference product, ensuring that both physician and patient are appropriately informed about the medication being dispensed;
• The label for a biosimilar must include the nonproprietary name and any differences in safety or effectiveness data that is unique to the biosimilar;
• Biosimilars should undergo clinical testing for each condition for which the reference product is approved.

The FDA approved the first biosimilar in March and several other applications are currently under review. FDA has not yet answered critical remaining implementation questions, leaving patients and physicians in the dark about how these new drugs will function in the marketplace. Additionally, FDA has not yet issued notice and comment rulemaking on interchangeability and naming, instead releasing draft guidance documents that provide no meaningful opportunity for input from patients and physicians.