Hospira Submits New Biologics License Application to FDA for Proposed Epoetin Alfa Biosimilar
Hospira, Inc. has submitted a Biologics License Application (BLA) to the FDA for Retacrit, a proposed biosimilar to Amgen's Epogen (epoetin alfa) and Janssen's Procrit (epoetin alfa).
The biosimilar application was submitted on 16 December 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
"As one of the first companies to submit a biosimilar application in the US, 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, senior vice president, chief scientific officer, Hospira. "Hospira is proud to build upon our global experience of providing biosimilars to patients across the world."
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