MedPage Today June 20, 2024
— New rules would mean switching studies will generally not be needed
The FDA on Thursday announced that biosimilars seeking an interchangeable status would no longer require studies showing that switching between a biosimilar and its branded reference product does not present any potential safety risks or risk of diminished efficacy.
In new draft guidance, the agency is suggesting a “revised approach where such studies will generally not be needed.”
Any physician can prescribe a biosimilar in place of a branded reference product, but the interchangeable status brings the advantage of being able to be substituted without need for a prescription change at the pharmacy level in some states, similar to generic drugs.
“The recommendations in today’s draft guidance, when...
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