FDA Advisory Panel Urges Approval Of First U.S.-Licensed Epoetin Alfa Biosimilar

FDA’s oncology drug advisory panel voted 14-1 Thursday (May 25) to support approval of Hospira's epoetin alfa biosimilar, despite multiple advisory panel members expressing concerns over potential immunogenicity risks in certain patient populations. The one advisory panel member who voted against supporting approval did so because of lack of data regarding immunogenicity in two of the four indications. While Hospira’s epoetin alfa biosimilar has been available in Europe for nearly a decade, FDA stressed that it did not have a...