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

 
• By Sue Sutter

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.

Pfizer Inc. is working to resolve lingering compliance issues at a legacy Hospira Inc. manufacturing facility that have blocked its bid to bring the first biosimilar version of epoetin alfa (Amgen Inc.’s Epogen/Johnson & Johnson’s Procrit) to the US market.

On June 22, Pfizer announced receipt of an FDA complete response letter a day earlier for its epoetin alfa biosimilar (proposed trade name Retacrit)

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