FDA Takes Up Hospira Biosimilar Of Epogen, Must Decide By October

February 12, 2015 at 1:59 PM
FDA has agreed to review Hospira, Inc.'s biosimilar application for an epoetin alfa biosimilar called Retacrit, according to a letter Wednesday (Feb. 11), coming in the wake of the agency's announcement it will hold an advisory committee meeting next month on a separate infliximab biosimilar that Hospira is developing with Celltrion. This marks the fourth biosimilar application that industry has said FDA has agreed to review, although the agency recently alluded that it has received a fifth application. Hospira filed...


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