Complete Response Letter delays approval for Retacrit (epoetin alfa biosimilar).- Hospira/Pfizer
In a Complete Response Letter relating to Retacrit (epoetin alfa biosimilar) from Hospira/Pfizer ,the FDA has rejected the application citing a previous warning letter sent to the the company about manufacturing violations at its McPherson, Kansas plant. Pfizer had listed the facility as a potential production site for the biosimilar candidate on its Biologics License. This action is likely to delay approval.
The problems at the plant was described in a warning letter that criticised Pfizer for repeated failings throughout the Hospira manufacturing network. The FDA said Pfizer should have recognized long ago there were issues that needed addressing because the agency had cited five other Hospira plants for similar problems in four warning letters issued in 2010, 2013, 2014 and 2015. Pfizer bought Hospira in 2015 in a $15 billion deal..
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