FDA to review Hospira's EPO biosimilar

Hospira Inc. (NYSE:HSP) said FDA accepted its BLA for Retacrit, a biosimilar of anemia drug Epogen epoetin alfa from Amgen Inc. (NASDAQ:AMGN) and Procrit epoetin alfa from the Janssen Biotech unit of Johnson & Johnson (NYSE:JNJ).

Hospira submitted its application on Dec. 16; the 10-month user fee goal for an FDA regulatory decision is Oct. 16. Hospira's BLA is the first disclosed application the agency has accepted for a biosimilar of epoetin alfa, an erythropoietin receptor agonist. ...