US FDA Biosimilar Standards Likely Sealed Interchangeability Designation’s Fate

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

FDA standards for biosimilar and interchangeable products largely are the same. (Shutterstock)

The US Food and Drug Administration’s high biosimilar approval standards appear to have streamlined its ability to deem all of the products interchangeable, should Congress enact the necessary legislation.

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