Hospira submits new BLA for epoetin alfa biosimilar In USA

US injectable drugs and infusion technologies and biosimilars developer Hospira (NYSE: HSP) has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for Retacrit (epoetin zeta), a proposed biosimilar to biotech major Amgen's (Nasdaq: AMGN) Epogen (epoetin alfa) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Procrit (epoetin alfa).

Epogen and Procrit are used in the treatment of chemo-therapy-induced anemia. The biosimilar application was submitted on December 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Retacrit has been approved in Europe and has been market in some countries since 2008.

"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 health care system decrease unsustainable costs by embracing a new frontier in medicine," said Sumant Ramachandra, senior vice president, chief scientific officer, Hospira, adding: "Hospira is proud to build upon our global experience of providing biosimilars to patients across the world."