Hospira's Epoetin Alfa Biosimilar Rejected, Company Says Additional Evidence Will Support Approval

FDA has rejected Hospira's application for an epoetin alfa biosimilar product, but a spokesperson for parent company Pfizer said Hospira will provide FDA additional information it is confident will lead to the biosimilar's approval and doesn't anticipate any further clinical trials are needed. Hospira submitted the original application in December. The rejected product -- which is a biosimilar of Amgen's Epogen and Janssen's Procrit -- is at the center of a biosimilar patent lawsuit, in which Amgen alleges that Hospira...