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FDA Approves Biosimilar to Epoetin Alfa for Anemia

On May 15, 2018, the Food and Drug Administration approved epoetin alfa-epbx (Retacrit, Hospira Inc.) as a biosimilar to epoetin alfa (Epogen/Procrit, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Read the FDA announcement here.

Posted 5/15/2018