Pfizer Inc.'s proposed epoetin alfa biosimilar has been recommended for approval across all indications by the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC).
The recommendation is a first among biosimilar erythropoiesis-stimulating agents (ESA). According to Pfizer, the positive recommendation was based on the committee’s review of comparable efficacy and safety to reference product Epogen and Procrit.
Pfizer is seeking FDA approval for the drug to treat anemia stemming from a variety of issues, including chronic kidney disease in patients both on and not on dialysis; Zidovudine in HIV-positive patients; concomitant myelosuppressive chemotherapy’s effects; and a reduction of allogeneic red blood cell transfusions in patients undergoing surgery.
“The committee’s recommendation reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them,” Diem Nguyen, global president of the Americas for Pfizer Essential Health, said in a statement. “Following the approval and launch of Inflectra (infliximab-dyyb) in 2016, this positive recommendation – a first for a proposed ESA biosimilar – marks an important milestone for Pfizer’s U.S. biosimilars portfolio.”