BioCentury
ARTICLE | Clinical News

Retacrit regulatory update

April 21, 2017 9:09 PM UTC

FDA's Oncologic Drugs Advisory Committee will meet on May 25 to discuss a BLA from Pfizer’s Hospira Inc. unit for Retacrit epoetin alfa, a proposed 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 resubmitted the BLA in December 2016. The erythropoietin (EPO) receptor agonist received a complete response letter from FDA in 2015 (see BioCentury, Feb. 8).

Last week, FDA lifted REMS requirements for use of Epogen/Procrit among patients with anemia due to associated myelosuppression chemotherapy. The agency said the REMS had minimal impact and was not necessary to ensure that treatment benefit outweighed risks, based on its own analysis and a review of data submitted by Amgen...