This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement
This guidance provides an overview of important scientific considerations in demonstrating interchangeability with a reference product, including the following:
Data and information needed to support a demonstration of interchangeability
Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability
Considerations regarding the comparator product in a switching study or studies
Abbreviated considerations for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products