Jan. 12--Lake Forest-based Hospira has submitted its first biologics license application to the Food and Drug Administration for a drug that treats anemia.
The drug helps the body produce red blood cells, alleviating anemia, a condition that can deplete the energy of patients undergoing chemotherapy or who have chronic renal failure.
The drug proposed by Hospira, called Retacrit, is a biosimilar, essentially a generic form of existing biotechnology treatments made from living cells. Retacrit received approval in Europe in 2008.
Another Hospira biosimilar, Nivestim, which helps stimulate the production of white blood cells from bone marrow, was approved in Europe in 2010 and in Australia in 2011.
Generic forms of chemical drugs such as cholesterol reducer Lipitor or antidepressant Prozac have been available for years to patients at significantly reduced costs.
Now drugs in the relatively new biologics category are mature enough that they legally can be imitated by other companies. Hospira's biosimilar would be comparable to Amgen's drug Epogen and Janssen Biotech's Procrit.
The first formal application for a biosimilar came in July from Novartis for a version of Amgen's biotech cancer drug Neupogen. Approval could come in March.
Hospira has said it has nearly a dozen biosimilars, potentially worth $40 billion, in its U.S. pipeline.
ehirst@tribpub.com
Twitter @ellenjeanhirst
