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