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FDA Issues Complete Response Letter for Epoetin Alfa Biosimilar

Jason Harris
Published: Friday, Jun 23, 2017

FDA
The FDA has rejected Hospira’s a biologics license application (BLA) for the epoetin alfa biosimilar, epoetin hospira (Retacrit), citing manufacturing concerns at the company’s fill-finish facility in McPherson, Kansas.

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
This marks a rare instance of the FDA denying a drug recommended by the Oncologic Drugs Advisory Committee (ODAC). The committee voted 14-1 to approve the BLA on May 25.

Epoetin hospira has been approved in Europe for the treatment of anemia associated with chronic renal failure since 2008.
U.S. Food & Drug Administration. Warning Letter. https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm542587.htm. Issued February 14, 2017.

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