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US Biosimilars: 40% First-Cycle Approval Rate Leaves Room For Improvement

 
• By Sue Sutter

Four of first 10 publicly disclosed applications were approved on first review cycle, and FDA has issued at least seven complete response letters. Increasing first-cycle approvals is a primary goal of the BsUFA II agreement.

FDA entrance sign 2016

Five years into the legislation that created FDA's biosimilar user fee system, a 40% first-cycle approval rate for publicly disclosed applications leaves ample room for progress under the program's next iteration.

While FDA has consistently met its Biosimilar User Fee Act (BsUFA) performance goals for reviewing and acting on a set percentage of original 351(k) application submissions within 10

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