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BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?

 
• By Derrick Gingery

Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.

User Fee Reauthorization Preview 2020
BsUFA III could be designed to help boost growth of the US biosimilar industry. • Source: Pink Sheet illustration

The US FDA's biosimilar program may have grown enough that it needs a formal – and potentially user fee-funded – research component to help advance the field.

Industry officials are just beginning to generate ideas for biosimilar user fee reauthorization discussions, which are expected to begin in the coming months

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