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Biosimilars Poll: What Should Qualify for Interchangeable Status?


How quickly and easily biosimilars should be declared interchangeable with reference products has been an ongoing issue.

Person voting with a ballot box

Interchangeable status for biosimilars under current FDA policy allows pharmacists to fill prescriptions with these agents instead of more costly originator drugs, without having to seek approval from a patient’s physician. But interchangeable status requires an additional layer of FDA review and is not automatically granted with FDA approval of each new biosimilar; and no biosimilars, insulin or otherwise, have yet achieved this status.

Which of the following best describes your opinion on allowing biosimilars to be used interchangeably with originator biologics?

All biosimilars should have automatic interchangeable status when first approved.
Only insulin biosimilars should have automatic interchangeable status.
Interchangeable status should continue to be granted only upon secondary FDA review.
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