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News From the Food and Drug Administration
June 19, 2018

Biosimilar Approved for Anemia

JAMA. 2018;319(23):2372. doi:10.1001/jama.2018.7764

The first biosimilar to epoetin alfa for patients with anemia from chronic kidney disease, chemotherapy, or zidovudine treatment for HIV infection has received FDA approval.

Marketed as Retacrit, epoetin alfa-epbx also is approved for use before and after surgery to reduce patients’ chances of needing red blood cell transfusions because of blood loss during surgery. The drug was approved as a biosimilar, not an interchangeable product.