ARTICLE | Clinical News

Retacrit epoetin zeta regulatory update

November 9, 2015 8:00 AM UTC

FDA issued a complete response letter for a BLA from Pfizer’s Hospira Inc. subsidiary for Retacrit epoetin zeta, a biosimilar of anemia drugs Epogen epoetin alfa from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) and Procrit epoetin alfa from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.). Pfizer expects it will not have to conduct new clinical trials. The pharma plans to submit a response in 1H16 and expects FDA action in 2H16. Pfizer did not respond to inquiries regarding the details of the letter. Hospira markets Retacrit in Europe. Epoetin alfa is an erythropoietin (EPO) receptor agonist. ...