Interchangeability: FDA Sets ‘Stringent’ Standard On Design Differences

Labeling Comparison: Conduct a side by side, line-by-line review of the full prescribing information, instructions for use, and descriptions of the container closure systems and/or delivery device constituent parts.
Comparative Task Analysis: Systematically dissect the use process for each product and analyze and compare the sequential and simultaneous manual and intellectual activities for end users interacting with both products.
Physical Comparison: Conduct a visual and tactile examination of the physical features.

24 Jan 2017

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FDA’s recently released draft guidance on interchangeability considerations discusses how differences in product presentation between a biosimilar and...