Earlier this week, Pfizer (NYSE: PFE) confirmed that the United States Food and Drug Administration’s Oncologic Drugs Advisory Committee had recommended approval for their epoetin alfa biosimilar for all indications. The announcement marks the first time a FDA Advisory Committee has recommended approval for a biosimilar erythropoiesis-stimulating agent. The Committee based their decision on the totality of the evidence, including the safety of the reference product, Epogen and Procrit.
At this point in time, Pfizer wishes to gain FDA approval to use the product for several purposes, including the following.
- Treatment of anemia due to:
- Chronic Kidney Disease
- Zidovudine in HIV patients
- The side effects of concomitant myelosuppressive chemotherapy
Simultaneously, the company hopes to use the drug to reduce allogeneic red blood cell transfusions in patients going through electric, nonvascular, noncardiac surgery.
The FDA will take the recommendation into consideration when weighing their decision to approval or deny the company’s Biologics License Application. Pfizer has already signed into an agreement with Vifor Pharma to commercialize the proposed epoetin alfa biosimilar across specific channels.