FDA finalizes rules for when a biosimilar is 'interchangeable' with a biologic - STAT

FDA finalizes rules for when a biosimilar is 'interchangeable' with a biologic - STAT

STAT Plus: FDA finalizes rules for when a biosimilar is “interchangeable” with a biologic

By NICHOLAS FLORKO AND ED SILVERMAN

ANDREW HARNIK/AP

The FDA spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug.

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