FDA rejected Pfizer’s Biologics License Application for its proposed epoetin alfa biosimilar to Amgen’s Epogen, citing significant violations of good manufacturing practice regulations for finished pharmaceuticals at the company’s drug manufacturing facility, Hospira Inc., in McPherson, KS.
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
