Hospira Inc. has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Retacrit, a proposed biosimilar to Amgen's EPOGEN (epoetin alfa) and Janssen's PROCRIT (epoetin alfa).
The biosimilar 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 (BPCIA).
"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."
Biosimilars are biologic drugs that are highly similar to a reference biopharmaceutical product and demonstrate no clinically meaningful differences in terms of the safety, purity and potency of the product.