Vizient shares feedback on FDA’s biosimilar interchangeability guidance

IRVING, Texas, August 20, 2024 - Today, Vizient, Inc. submitted comments to the Food and Drug Administration (FDA) regarding its draft guidance, Considerations for Demonstrating Interchangeability with a Reference Product: Update. The draft guidance aims to revise the agency's May 2019 guidance with new information for manufacturers seeking approval for interchangeable biosimilars.

In our comments, Vizient expressed strong support for FDA's decision to eliminate the requirement for switching studies to demonstrate interchangeability with a reference product, reiterating the undue burden and unnecessary nature of such studies. Additionally, Vizient applauded the agency for its efforts to rely on more recent data and experience in evaluating products to streamline approvals of interchangeable biosimilars.

"By reconsidering the need for switching studies and instead allowing applicants to leverage comparative analytical and clinical data to support that the statutory requirements are met, the FDA streamlines the path to interchangeability, which can lead to more interchangeable biosimilar approvals, and ultimately improve access to affordable and innovative treatments," said Steven Lucio, PharmD, BCPS, senior principal, pharmacy solutions for Vizient. "Vizient strongly supports this change and urges FDA to promptly finalize the draft guidance."

Vizient remains committed to providing ongoing insights to the FDA to enhance the biosimilar review process, while also ensuring that pharmacists, physicians, and other healthcare professionals are well-informed and prepared to navigate this evolving landscape.

Learn about Vizient's biosimilar insights and solutions.