Biosimilars Council Applauds Updated FDA Guidance on Interchangeability

The Biosimilars Council applauds the FDA for updated draft guidance released on June 20, 2024—regarding switching studies intended to support a demonstration that a biological product is interchangeable with a reference product.

The draft guidance, titled, “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product.

“Biosimilars – with and without an interchangeability designation – are safe and effective, and lower price options for patients,” said Craig Burton, Executive Director, Biosimilars Council. “This FDA action is consistent with the Council’s recommendations and will maintain the FDA’s high standards of safety while speeding up patient access to essential medicines.”

The FDA also published an educational article on June 20, 2024 – highlighting nine important facts around biosimilars and interchangeable biosimilars. This easy to access tool is essential for those wanting to learn more about this important topic.

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About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.