FDA Releases Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.”-Drug Information Update

Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Today, FDA released Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.” The guidance provides an overview of important scientific considerations in demonstrating interchangeability and is intended to assist applicants in demonstrating that a proposed therapeutic protein product (e.g., monoclonal antibodies) is interchangeable with a reference product under section 351(k) of the PHS Act.

Among other things, this guidance contains information on:

• Factors impacting the type and amount of data and information needed to support a demonstration of interchangeability;
• The 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;
• Recommendations regarding the use of U.S.-licensed reference products in a switching study or studies; and
• Considerations for developing presentations (e.g. container closure systems) for proposed interchangeable products.

In addition to soliciting comments on the draft guidance, the FDA also invites comments on questions posed in the notice of availability (NOA) about interchangeability in general, regulation of interchangeable products over their lifecycle and questions about considerations regarding post-approval manufacturing changes.  

An interchangeable biological product is biosimilar to the reference product; and can be expected to produce the same clinical result as the reference product in any given patient.  In addition, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. The approval pathway for biosimilar and interchangeable products was established by the Biologics Price Competition and Innovation Act of 2009, which was enacted as part of the Affordable Care Act in March 2010. 

FDA also released a CDER From Our Perspective by Leah Christl describing aspects of this draft guidance.

For more information on how to submit comments on the draft guidance and questions posed in the Notice of Availability, see the Federal Register notice.