On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be submitted without intervention. The guidance focuses on therapeutic protein products, providing an overview of scientific considerations in showing interchangeability of a proposed therapeutic protein product with a reference product. It pertains to a series of guidance documents FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009. This final guidance provides sponsors with more certainty on the development of these proposed interchangeable products. Its scope includes scientific considerations of:
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The data and information needed to support a demonstration of interchangeability;
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The design and analysis of a switching study or studies to support a demonstration of interchangeability;
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The comparator product in a switching study or studies; and
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The development of presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products.
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