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All Biosimilars Interchangeable? FDA Backs Switching With Spotlight On Science

Latest Review From US Agency Finds ‘Zero Difference’ In Risks When Switching

Executive Summary

In meta-analyses of biosimilar switching studies, FDA researchers found ‘zero difference in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch.’

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Generics Bulletin Explains: Removing Interchangeability Information From US Biosimilar Labels

A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.

From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels

Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.

US Bill Takes Another Shot At Biosimilar Interchangeability

Draft legislation reintroduced in the US is seeking to remove the need for switching studies to demonstrate biosimilar interchangeability, making all approved biosimilars automatically interchangeable.

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