US FDA advisory committee members overwhelmingly recommended approval of Hospira Inc.'s epoetin product, a proposed biosimilar of Amgen Inc.'s Epogen (epoetin alfa), despite concerns about two of its potential indications and immunogenicity risks.
Some members of the Oncologic Drugs Advisory Committee recommended a significant postmarketing program during the May 25 meeting. FDA advisory panelist have often pushed for more postmarketing of some biosimilar indications – in case, looking closely at patients with cancer or HIV who would receive Hospira's epoetin for anemia – but the
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