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.
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FDA's Leah Christl and Amgen and Sandoz representatives discuss key achievements of BsUFA II at DIA meeting; Christl expects to see interchangeable biosimilars come to market within the next two years.
US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.
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