The U.S. Food and Drug Administration (FDA) issued final guidance for industry "Considerations in Demonstrating Interchangeability With a Reference Product" and announced the release in an FDA statement. 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 the Public Health Service Act (PHS Act).

An interchangeable product is a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of fulfilling these additional requirements, information is needed to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient. Also, for products administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will have been evaluated and determined to be not greater than the risk of using the reference product without switching.

This guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product, including:

• The data and information recommended 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
• High-level overview of considerations for developing presentations for proposed interchangeable products

This guidance finalizes the draft guidance issued on January 17, 2017. Changes made to the guidance took into consideration the comments received. FDA provided changes to clarify its recommendations for demonstrating interchangeability with the reference product. FDA intends to provide more detailed recommendations on the data and information recommended to support the proposed interchangeable product’s presentation, container closure systems, and delivery device constituent parts and related issues in a separate guidance.

This final guidance provides sponsors with increased clarity on approaches for demonstrating interchangeability of a proposed therapeutic protein product with a reference product, while maintaining the Agency’s rigorous scientific standards for interchangeable biological products. This guidance is one in a series of guidances that FDA has developed to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

The FDA is committed to advancing the pathway for biosimilar and interchangeable products, including work to provide greater regulatory and scientific clarity for biosimilar and interchangeable applicants and other stakeholders as outlined in the Biosimilars Action Plan (BAP). The availability of biosimilar and interchangeable products can provide more treatment options, potentially lowering treatment costs and enabling greater access for more patients.

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