BioCentury
ARTICLE | Clinical News

Retacrit regulatory update

February 8, 2017 10:48 PM UTC

Pfizer said it resubmitted a BLA to FDA for Retacrit epoetin alfa, 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.). In 2015, FDA issued a complete response letter for a BLA from Pfizer’s Hospira Inc. subsidiary for the erythropoietin (EPO) receptor agonist (see BioCentury, Nov. 9, 2015)...

BCIQ Target Profiles

Erythropoietin (EPO) receptor