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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

 
• By Dave Wallace

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.”

No Difference - dictionary definition
The FDA found biosimilar switching produced “zero difference” in key risks • Source: Shutterstock

US Food and Drug Administration research highlighted by the agency’s Center for Drug Evaluation and Research in a “spotlight on CDER science” has concluded that switching between branded biologics and biosimilars produces “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.”

The project saw FDA researchers conduct a systematic review and meta-analysis using statistical methods to determine whether there were...

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