ARTICLE | Company News

Biosimilar siege on Amgen continues

January 13, 2015 3:24 AM UTC

Hospira Inc. (NYSE:HSP) said it submitted a BLA to FDA for Retacrit, its proposed 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 reported that it submitted the application on Dec. 16, 2014; the 10-month user fee goal for an FDA regulatory decision is Oct. 16, 2015.

The submission is Hospira's first in the U.S. for a biosimilar, and is the first announced U.S. submission for a biosimilar of epoetin alfa, an erythropoietin receptor agonist. ...