Hospira Submits Retacrit Regulatory Application to the FDA

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Earlier this week, Hospira, Inc. (HSP) announced that it has submitted a Biologics License Application (BLA) looking to get Retacrit approved in the U.S. The drug is a proposed biosimilar to Amgen Inc.’s (AMGN) Epogen (epoetin alfa) and Janssen's Procrit (epoetin alfa). Janssen is a division of Johnson & Johnson (JNJ).

Hospira stated that on Dec 16, 2014, it had submitted the biosimilar application, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009.

Epogen is indicated to treat a lower-than-normal number of red blood cells caused by chronic kidney disease in patients on dialysis to reduce or avoid the need for red blood cell transfusions. Procrit is also used to treat a lower-than-normal number of red blood cells if it is caused by chronic kidney disease and certain other indications.

The company has a lucrative biosimilars pipeline. As of Sep 3, 2014, Hospira's biosimilar pipeline consisted of up to 11 compounds. The company’s biosimilar pipeline is potentially worth multi-billion dollars. In the third quarter of 2014, the company witnessed strong sales volume for biosimilars in the Europe, Middle East and Africa (EMEA) segment.

Hospira currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Allergan (AGN) carrying a Zacks Rank #1 (Strong Buy).

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