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Interchangeability: FDA Sets ‘Stringent’ Standard On Design Differences

 
• By Sue Sutter

Sponsors must assess any differences in a biosimilar’s container closure system or delivery device relative to the US reference product and may need to conduct comparative use human factor studies to ensure there is no increased risk of use-related error with the biosimilar.

The US FDA has shown a willingness to license biosimilars with container closure systems or delivery devices that differ from the reference biologic, but interchangeability determinations may be harder to come by for such products.

FDA’s recently released draft guidance on interchangeability considerations discusses how differences in product presentation between a biosimilar and reference product might impact the former’s ability to demonstrate interchangeability.

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More from Policy & Regulation

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