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BsUFA III Negotiations Nearly Done; Commitment Letter Being Written

 
• By Derrick Gingery

Supplement approval timeline and regulatory science issues apparently have been resolved.

FDA website
When BsUFA III talks end, only the generic drug user fee reauthorization negotiations will remain ongoing • Source: Alamy

Biosimilar user fee reauthorization negotiations are nearly completed, making the program the second of three drug and biologic-related programs ready to complete the first step toward another five-year extension.

A source with knowledge of the negotiations told Generics Bulletin sister publication the Pink Sheet that commitment letter language is now under

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