FDA Rejects Hospira’s Epogen Biosimilar

Last year, Hospira, Inc. (owned by Pfizer, Inc.) submitted an abbreviated Biologics License Application (aBLA) for its proposed biosimilar to Amgen’s Epogen (epoetin alfa).  The biosimilar has been available in Europe since 2008  – under the name of Retacrit – for the treatment of anemia associated with chronic renal failure.  On its quarterly earnings call, Pfizer revealed that the FDA has rejected Hospira’s application.  However, Pfizer also stated that it has additional evidence to support approval of the biosimilar, thus it appears that Pfizer and Hospira may amend the application and try again.  Stay tuned to the Big Molecule Watch for further developments on this issue.