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

 
• By Derrick Gingery

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.

Questions to be answered
Labeling, promotional and other draft interchangeability guidances are required to be issued during BsUFA III. • Source: Alamy

Planned research and new guidances included in the reauthorization of the US FDA’s biosimilar user fee program should help answer several lingering interchangeability and biosimilar development questions.

One of the demonstration projects in the BsUFA III regulatory science program will “investigate and evaluate the data and information, including real-world evidence, needed to meet the safety standards for determining interchangeability,” according to the

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