Biosimilars Council applauds updated FDA guidance on interchangeability
The Biosimilars Council applauds the FDA for updated draft guidance regarding switching studies intended to support a demonstration that a biological product is interchangeable with a reference product.
The draft guidance, titled, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” describes considerations regarding a switching study or studies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 of the 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.”
[Read more: Prioritizing Lower-Priced Biosimilar Medications]
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.
[Read more: Biosimilars Council calls for more efficient regulatory pathways for critical medicines]