Real-World Evidence Under Consideration For Use In Interchangeable Biosimilar Applications
Planned Research And Guidances Included As Part Of BSUFA III
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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Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.
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