FDA Approves Retacrit, First Biosimilar Epoetin Alfa

May 16, 2018

Biosimilars Team

The Food and Drug Administration (FDA) has approved Retacrit (epoetin alfa-epbx; Hospira Inc.), the first biosimilar epoetin alfa (Epogen, Amgen Inc.; Procrit, Janssen Products, LP). Epoetin alfa is an erythropoiesis-stimulating agent (ESA); Retacrit is the first and currently only biosimilar ESA to be approved in the United States.

Retacrit is administered by subcutaneous injection or intravenous infusion. It is approved for all eligible indications:

  • Treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis.
  • Treatment of anemia due to zidovudine administered at ≤4200 mg/week in patients with HIV infection.
  • Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
  • Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Retacrit is not approved as an interchangeable product.

Similar to Epogen and Procrit, the labeling for Retacrit contains a Boxed Warning to alert health care professionals and patients about increased risks of death, heart problems, stroke, and tumor growth or recurrence. Retacrit also must be dispensed with a patient Medication Guide that provides information about the drug’s uses and risks.

Hospira’s parent company, Pfizer, expects Retacrit to be available in the United States at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit. Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of Retacrit in certain channels.