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ODAC Recommends Approval of Epoetin Alfa Biosimilar

Jason Harris
Published: Thursday, May 25, 2017

FDA
The FDA’s Oncologic Drugs Committee voted (ODAC) 14-1 today to recommend approving a biologics license application (BLA) for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira.

Hospira was seeking approval for 4 indications:
  • to treat anemia due to chronic kidney disease, including patients on dialysis and not on dialysis to decrease the need for red blood cell transfusion
  • to treat anemia in HIV-infected patients being treated with zidovudine
  • to treat chronic renal failure, specifically anemia caused by concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancy
  • to reduce the need for allogeneic red blood cell transfusions in patients with perioperative hemoglobin from >10 g/dL to ≤13 g/dL who are at high risk for perioperative blood loss from elective noncardiac, nonvascular surgery
Although the vote was nearly unanimous, many committee members expressed concern about immunogenicity, especially in patients with HIV or cancer. Those patient populations were not as extensively studied when epoetin alfa was first approved in 1989.
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