Considerations in Demonstrating Interchangeability With a Reference Product

The U.S. FDA has issued a new guidance document “Considerations in Demonstrating Interchangeability With a Reference Product”.

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 under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).

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.

See: https://www.fda.gov/media/124907/download

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology