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Hospira's Epogen Biosimilar Appears Poised For Quick Advisory Cmte. OK

Executive Summary

US FDA will hold its first-ever half-day panel review for a biosimilar; Hopsira's epoetin, which references Amgen's Epogen, has no clinically meaningful differences despite clinical trial conduct issues and PK/PD uncertainty, agency concludes.

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Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

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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