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ARTICLE | Clinical News

ODAC backs Pfizer biosimilar Retacrit

May 26, 2017 5:34 PM UTC

FDA's Oncologic Drugs Advisory Committee voted 14-1 in favor of approval of Retacrit epoetin alfa from Pfizer Inc. (NYSE:PFE). The candidate is a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ).

The panel recommended Retacrit's approval to treat all of the reference products' indications, which include anemias associated with chronic kidney disease (CKD), chemotherapy and perioperative settings. It is the first FDA approval for a biosimilar of Epogen or Procrit...