FDA advisory panel recommends approval of Epogen/Procrit biosimilar

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of the proposed epoetin alfa biosimilar across all indications by a vote of 14 to one, says US pharma giant Pfizer (NYSE: PFE).

This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a US FDA Advisory Committee. This is a biosimilar to blockbuster anemia drugs Amgen’s (Nasdaq: AMGN) Epogen and Johnson & Johnson's (NYSE: JNJ) Procrit.

Panelist Dr Thomas Uldrick, clinical director of the HIV & AIDS Malignancy Branch at the National Cancer Institute, voted against approving the biosimilar, though he noted that he "strongly" supports approval for two of the four indications.