Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar
By Zachary Brennan -
Published 10 August 2017
The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.
Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Regulatory strategy
Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen
FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote
By Michael Mezher -
Published 25 May 2017
The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.
Categories: News, US, FDA, Biologics and biotechnology, Submission and registration
Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar