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MAY 15, 2018

First Epoetin alfa Biosimilar Receives FDA Approval for Anemia

By SPC News Staff

The FDA approved epoetin alfa-epbx (Retacrit, Pfizer) as a biosimilar to Epogen/Procrit (epoetin alfa (Epogen/Procrit, Amgen) to treat anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with HIV infection. Epoetin alfa-epbx is approved as a biosimilar, not an interchangeable product.

Epoetin alfa-epbx also is approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss