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Real-World Evidence Under Consideration For Use In Interchangeable Biosimilar Applications

Planned Research And Guidances Included As Part Of BSUFA III

Executive Summary

US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.

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