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August 20, 2024 – Today, Vizient, Inc. submitted comments to the Food and Drug Administration (FDA) regarding its draft guidance, Considerations for Demonstrating Interchangeability with a Reference Product: Update. The draft guidance aims to revise the agency's May 2019 guidance with new information for manufacturers seeking approval for interchangeable biosimilars.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 "Vizient strongly supports this change and urges FDA to promptly finalize the draft guidance."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.
About Vizient, Inc.
Vizient, Inc., the nation's largest provider-driven healthcare performance improvement company, serves more than 65% of the nation's acute care providers, including 97% of the nation's academic medical centers, and more than 35% of the non-acute market. The Vizient contract portfolio represents $140 billion in annual purchasing volume enabling the delivery of cost-effective, high-value care. With its acquisition of Kaufman Hall in 2024, Vizient expanded its advisory services to help providers achieve financial, strategic, clinical and operational excellence. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.