Demonstrating Interchangeability With a Reference Product/ GDUFA II Program Fee Request for Information and Comments/ CGMP Requirements for Combination Products

1. FDA Releases Draft Guidance for Industry: Considerations in Demonstrating Interchangeability With a Reference Product

Today, FDA released Draft Guidance for Industry: “Considerations in Demonstrating Interchangeability With a Reference Product.”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In addition to soliciting comments on the draft guidance, the FDA also invites comments on questions posed in the notice of availability (NOA) about interchangeability in general, regulation of interchangeable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FDA also released a CDER From Our Perspective by Leah Christl describing aspects of this draft guidance.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. 

2. Generic Drug User Fee Amendments (GDUFA) II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers; Request for Information and Comments

FDA is seeking information and public comment, in anticipation of the passage of GDUFA II, relevant to FDA’s planned approach for administering generic drug program fees under that legislation for fiscal year (FY) 2018. This includes requests for comment and information regarding FDA’s initial inventory of approved abbreviated new drug application sponsors and application numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA program fees in a timely manner. Submit written or electronic comments and information by March 10, 2017. Details are located in the Federal Register Notice.

3. Current Good Manufacturing Practice (CGMP) Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff

This guidance describes and explains the final rule on CGMP requirements for combination products that FDA issued on January 22, 2013. Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products, there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule did not establish any new requirements; it was intended to clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products, and to set forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable CGMP requirements.