The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled Considerations for Demonstrating Interchangeability with a Reference Product: Update. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.
"Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product," said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA.
FDA issued the guidance for industry Considerations in Demonstrating Interchangeability With a Reference Product (May 2019) (Interchangeability Guidance) before receiving and reviewing any biologics license applications (BLAs) submitted under section 351(k) of the Public Health Service Act (PHS Act) for a proposed interchangeable biosimilar. Since publication of the Interchangeability Guidance, experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product. Accordingly, FDA’s scientific approach to when a switching study or studies may be needed to support a demonstration of interchangeability has evolved. As described in this draft guidance, applicants for proposed interchangeable products may choose to provide an assessment of why the comparative analytical and clinical data provided in the application or supplement support a showing that the switching standard set forth in section 351(k)(4)(B) of the PHS Act has been met.
Per the FDA, this guidance is being distributed for comment purposes only. Submit Comments by 08/20/2024, the agency requests, to ensure that your comment can be considered on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
