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FDA Panel Shows Support for Epoetin Biosimilar

December 30, 2021

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 14-1 to recommend approval of an epoetin alfa biosimilar agent. If approved by the FDA, this would be the first erythropoiesis-stimulating biosimilar agent.

ODAC's decision was based on demonstrated efficacy compared with the reference product, and approval would apply to all of the FDA-approved indications for epoetin alfa, including:
treatment of anemia resulting from:

  • chronic kidney disease in patients on 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, non-cardiac, non-vascular surgery

Pfizer, the manufacturer of the biosimilar agent under review, is in the midst of a legal battle with Amgen, the manufacturer of the reference product, which claims that Pfizer provided its marketing notice for the biosimilar too early. Based on agreed-upon stipulations, makers of biosimilar products must provide 180-day marketing notices after FDA approval. This case is set to begin in September.

Sources: Pfizer press release, May 25, 2017; Pharma Times, May 26, 2017.


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