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