Biosimilars vs. Interchangeable Biological Products: FDA Fact Check
XTalks
FEBRUARY 8, 2021
Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. If the FDA licenses an interchangeable, that means that switching between the interchangeable and the reference doesn’t increase the safety risk or decrease the effectiveness compared to using the reference only,” says Brahme.
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