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As Biosimilar Meeting Requests Rise, So Do FDA's Performance Goal Challenges

 
• By Sue Sutter

Growing number of products participating in BsUFA program, coupled with budgetary challenges, have made FDA attainment of some early goals under the Biosimilar User Fee Act difficult.

FDA performance goals around biosimilar product sponsor meetings may warrant reconsideration in the next iteration of the Biosimilar User Fee Act (BsUFA) given challenges FDA has faced in reaching certain thresholds in the program's early years.

The agency's biosimilar program is currently in the third year of its initial, five-year authorization; it will need to be renegotiated and renewed before it expires in September 2017.

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