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FDA’s ODAC Recommends Approval of Epoetin Biosimilars

December 30, 2021

The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of an epoetin alfa biosimilar in a 14-1 vote. This is the first recommendation of its kind for a biosimilar erythropoiesis-stimulating agent (ESA).

ODAC's decision was based on demonstrated efficacy compared to the original product and applies to all of the approved indications for epoetin alfa:

  • treatment of anemia resulting from:
    • chronic kidney disease (CKD) in patients on dialysis and not on dialysis
    • zidovudine in HIV-infected patients
    • the effects of concomitant myelosuppressive chemotherapy
  • reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery

The FDA will consider this recommendation when evaluating the drug's Biologics License Application.

The FDA recently dropped its risk evaluation and mitigation strategy requirements for ESAs.

Source: Pfizer press release, May 25, 2017.


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