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FDA To Pilot Biosimilar Regulatory Science Program

Scheme Will Focus On Advancing Interchangeable Development And Improving Efficiency

 
• By Chloe Kent

As part of BsUFA III, the FDA has announced that it will be commencing its regulatory science research program, which will focus on advancing the development of interchangeable products and biosimilars.

Official homepage of the FDA
The FDA is examining interchangeability as part of the program • Source: Shutterstock

The US Food and Drug Administration is set to pilot a regulatory science program that focuses on advancing the development of interchangeable products and improving the efficiency of biosimilar product development, under the Biosimilar User Fee Act reauthorization commitment letter for the fiscal years 2023 to 2027.

BsUFA III’s regulatory science program will center its efforts on enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational...

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