FDA Rejects Epoetin Alfa Biosimilar After Advisory Panel Recommends Approval

Pfizer announced Thursday (June 22) that FDA has rejected its epoetin alfa biosimilar due to good manufacturing practice violations, despite an advisory committee recommending approval last month. Pfizer’s application, which was filed by its subsidiary Hospira, if approved would have been the first epoetin alfa biosimilar on the U.S. market. “Pfizer Inc…today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for...