FDA Updates Guidance on Interchangeability of Biosimilars

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance titled «Considerations for Demonstrating Interchangeability with a Reference Product: Update,» marking a significant development in the regulatory landscape for biosimilars. This draft guidance offers clarity on the considerations surrounding switching studies intended to demonstrate that a biological product is interchangeable with its reference product.

Key Points from the FDA’s Updated Guidance

The new draft guidance reflects the FDA’s updated scientific understanding and experience gained over the past decade in reviewing biosimilars and interchangeable biosimilars. According to Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars, «The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science.»

Dr. Yim emphasized that both biosimilars and interchangeable biosimilars meet the same rigorous standards for safety and efficacy as their reference products. This draft guidance builds on the FDA’s 2019 guidance on interchangeability, issued before any applications for interchangeable biosimilars had been reviewed. Since then, experience has shown that the risks associated with switching between a biosimilar and its reference product—whether in terms of safety or efficacy—are minimal.

Evolution in Scientific Approach

The FDA’s scientific approach to interchangeability has evolved significantly. Recent systematic reviews and meta-analyses conducted by the FDA found no significant differences in the risk of death, serious adverse events, or treatment discontinuations between patients who switched between biosimilars and reference products and those who did not.

Additionally, advances in analytical tools now allow for more precise and sensitive evaluations of biologic products, both in vitro (in the lab) and in vivo (in living organisms), reducing the reliance on switching studies. Historically, the FDA has recommended switching studies as part of the data package needed to demonstrate interchangeability. However, of the 13 approved interchangeable biosimilars to date, nine were approved without additional clinical data from switching studies. This indicates a shift in the FDA’s approach, as today’s draft guidance suggests that such studies may generally not be needed

Confidence in Biosimilars and Interchangeables

Health care professionals and patients can continue to have confidence in the safety and effectiveness of biosimilars, regardless of whether they are also approved as interchangeable. The FDA assures that biosimilars are as safe and effective as the originator biologics (reference products) they are compared against.

Invitation for Public Comment

The FDA encourages stakeholders to review the draft guidance and provide feedback. Interested parties can submit their comments via the Federal Register notice, contributing to the ongoing development of regulatory practices in this area.

For more information, the FDA has also developed a resource titled “9 Things to Know About Biosimilars and Interchangeable Biosimilars,” which provides an overview of this important topic for health care professionals and patients.

To read the full draft guidance and submit comments, please visit the official FDA notice here.

This article highlights the FDA’s commitment to ensuring the safety and efficacy of biosimilars and their interchangeable counterparts while adapting to advancements in scientific understanding and technology.

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