First ESA Biosimilar Gets FDA Advisory Committee Nod

This is the first time a biosimilar ESA has been recommended for approval by an FDA Advisory Committee
This is the first time a biosimilar ESA has been recommended for approval by an FDA Advisory Committee

Pfizer announced that the Food and Drug Administration (FDA)'s Oncologic Drugs Advisory Commtitee (ODAC) voted in favor to recommend approval of the epoetin alfa biosimilar for all indications. This is the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA Advisory Committee.

The Committee's recommendation was supported by its review of all the evidence, including efficacy and safety data of biosimilar epoetin alfa vs. the reference Epogen and Procrit products.

The proposed indications for the biosimilar are:

  • Treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, zidovudine in HIV-infected patients, and the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months planned chemotherapy
  • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery

The FDA will consider the Committee's recommendation before acting on the biologics license application (BLA) for the epoetin alfa biosimilar.

For more information visit Pfizer.com.