July 02, 2015
1 min read

Coalition surveys rheumatologists, calls for FDA action on biosimilars

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The Coalition of State Rheumatology Organizations has released the results of a survey of rheumatologists showing that most rheumatologists look forward to the availability of biosimilars, but also that they want the FDA to take specific regulatory steps to ensure patient safety, according to a press release.

“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,” Coalition of State Rheumatology Organizations (CSRO) president, Michael Schweitz, MD, FACR, MACR, said in the press release. “This survey affirms that further guidance from FDA on critical issues such as interchangeability and naming are needed before additional biosimilars are approved.”

More than 82% of respondents replied that rigorous safety testing should be required before labelling a biosimilar as interchangeable with the original drug, and more than 75% of rheumatologists surveyed said the new biosimilar must have a distinct name from the original biologic agent. Additionally, nearly 96% of the respondents said information about any differences between the biosimilar and the original biologic drug should be included in the labelling.

The CSRO called for the FDA to require clearly distinguishable names for the biosimilar to avoid confusion with the original product, clinical testing of the biosimilar and labelling that includes safety data, according to the release.

Reference: www.cqrcengage.com/csro.