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Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching

 
• By Derrick Gingery

Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.

FDA Biosimilar Check marks
FDA's biosimilar education campaign explains how biosimilars meet the same approval standards as their reference products. The agency tweeted this image as part of the campaign roll-out. • Source: FDA

The US FDA's new biosimilar information campaign does not tackle the non-medical switching controversy, but does attempt to dispel concerns about the difference between biosimilar and interchangeable products.

The effort, targeted at health care providers, is an attempt to answer questions about biosimilars and interchangeable products, including approval standards and development requirements.Commissioner Scott Gottlieb said in an Oct. 23

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More from Biosimilars & Generics

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