Hospira submitted a biologics license application to the FDA for Retacrit, a proposed biosimilar to Amgen's EPOGEN (epoetin alfa) and Janssen's PROCRIT.
According to a company-issued press release this week, the application was submitted on Dec. 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009.
News of their application comes less than a week after the FDA's Oncologic Drugs Advisory Committee unanimously recommended the approval of Sandoz' biosimilar that is comparable to Amgen's Neupogen. It signaled being one step closer to the U.S. approving their biosimilar.
"As one of the first companies to submit a biosimilar application in the United States, we are proud to be a leader who can help our country's healthcare system decrease unsustainable costs by embracing a new frontier in medicine," said Sumant Ramachandra, M.D., Ph.D., Senior Vice President, Chief Scientific Officer, Hospira."Hospira is proud to build upon our global experience of providing biosimilars to patients across the world."