Hospira Submits Epogen/Procrit Biosimilar Application, Fourth in U.S.

Hospira has submitted a BLA for anemia drug Retacrit, a proposed biosimilar to Amgen's Epogen and Janssen's Procrit — making it the fourth company to announce submission of a biosimilar application to the FDA.

Hospira said the filing for epoetin alfa was sent to the FDA on Dec. 16, 2014. The drugmaker said it expects FDA notification of acceptance of the submission within 60 days of filing. The FDA has committed for this fiscal year to acting on at least 80 percent of biosimilar applications within 10 months.

The announcement comes just a week after an FDA advisory committee considered the first biosimilar application. The agency’s Oncologic Drugs Advisory Committee voted unanimously to recommend approval of Sandoz’s Zarxio, a biosimilar to Amgen’s Neupogen (filgrastim).

Celltrion and Apotex are the other two companies with announced biosimilar applications. Hospira has a partnership with Celltrion giving it exclusive U.S. marketing rights to the South Korean firm’s biosimilar, if approved. No biosimilars have yet been approved under the 2010 pathway, and all are likely to face uphill patent battles against the brandmakers.

Hospira has long touted itself as a major international biosimilars firm, with products in Australian and European markets, including Retacrit, which Hospira launched in Europe in 2008 and Australia in 2011.

Amgen’s branded version of epoetin alfa, Epogen, earned the firm $518 million in worldwide sales in the third quarter of last year, according to an SEC filing. For Janssen, Procrit brought in $307 million in the same period.  

Epoetin alfa is approved in the U.S. to treat anemia in patients with chronic kidney disease who are on dialysis. It is also indicated for anemia in HIV-infected patients and cancer patients undergoing chemotherapy. — Bryan Koenig