Oncologic Drugs Advisory Committee

The Committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications are:(1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at ≤4,200mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤500munits/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to <13g/dL who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery.