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US Bill Takes Another Shot At Biosimilar Interchangeability

Draft Legislation Would Classify All Approved Biosimilars As Interchangeable

Executive Summary

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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All Biosimilars Interchangeable? FDA Backs Switching With Spotlight On Science

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.’

All Biosimilars Interchangeable? FDA Backs Switching With Spotlight On Science

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.”

Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity

As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

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