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Biosimilars Council applauds FDA for updated biological draft guidance

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WASHINGTON — The Biosimilars Council has applauded the FDA for updated draft guidance regarding switching studies intended to support a demonstration that a biological product is interchangeable with a reference product.

The draft guidance, titled, “Considerations for Demonstrating Interchangeability with a Reference Product: Update.”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, 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.


ECRM_06-01-22


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