Epoetin Biosimilar Approved for Treatment of Anemia | FDA


The US FDA has approved the first epoetin alfa biosimilar drug, Retacrit, (epoetin alfa – epbx) for the treatment of anemia.

Key Points

  • First biosimilar drug approved for epoetin alfa (Epogen/Procrit), a recombinant human erythropoetin
  • Approved to treat anemia due to CKD, chemotherapy, zidovudine use, or surgical hemorrhage
  • Epogen/Procrit currently accounts for significant % of Medicare spending, weekly treatments can cost $2,000


  • 3 Phase III studies w/ 1272 Patients
  • Has been approved for 10 years in EU
  • Safety, efficacy data statistically equivalent to Epogen/Procrit


What is a biosimilar drug?

The majority of drugs are chemically synthesized or extracted from natural products.  Generic versions of these drugs are chemically and functionally identical to their brand-name counterparts.

Biologic drugs are recombinantly produced in biological systems (e.g., in a vat of bacteria).  Biosimilars are like the generic versions of biologic drugs, functionally equivalent to their brand-name biologic counterparts, but may have differences on the molecular level.


Source: Press Announcements > FDA approves first epoetin alfa biosimilar for the treatment of anemia