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Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement

 
• By Derrick Gingery

Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

The completed BsUFA III agreement includes supplement timeline improvements. • Source: Illustration

Biosimilar user fee talks ended with confirmation that a regulatory science program will be created, resolving an issue that emerged at the start of the talks about three months prior.

The FDA agreed to an industry counterproposal to allow biosimilar regulatory science research during a 25 May meeting, according to meeting minutes, but at the final meeting, the two...

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