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Biosimilar User Fee Agreement Allows For Reliance On Foreign Clinical Data, FDAer Says

 
• By Sue Sutter

Agency interactions with sponsors under BsUFA are not dependent upon opening an IND. Sponsors may be able to demonstrate similarity to an FDA-licensed reference product by bridging to foreign clinical data, Associate Director for Biosimilars Leah Christl says.

FDA’s biosimilar user fee agreement enables agency/sponsor interactions about development programs that rely on foreign clinical data without the need for an investigational new drug application.

Biosimilar product sponsors may choose not to open an IND if they are conducting clinical trials in a foreign country, Leah Christl, associate director for biosimilars in FDA’s Office of...

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