BioCentury
ARTICLE | Clinical News

FDA approves Pfizer's Retacrit, first epoetin alfa biosimilar in U.S.

May 18, 2018 2:31 AM UTC

FDA approved Retacrit epoetin alfa-epbx from Pfizer Inc. (NYSE:PFE), a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). FDA said it is the first approved biosimilar of epoetin alfa, an agonist of the erythropoietin (EPO) receptor, in the U.S.

Pfizer said the approval covers all of Retacrit's reference products' indications. Those include anemia due to chronic kidney disease (CKD), use of zidovudine in HIV-infected patients and effects of concomitant myelosuppressive chemotherapy, and upon initiation, a minimum of two additional months of planned chemotherapy. The biosimilar is also approved to reduce allogeneic red blood cell transfusions in patients undergoing elective, non-cardiac, non-vascular surgery...