Hospira Submits Application for Epoetin Alfa Biosimilar to FDA

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The move represents Hospira’s first biosimilar submission in the United States.


On Jan. 12, 2015, Hospira announced it filed a biologics license application with the FDA for its anti-anemia drug Retacrit (epoetin alfa), a biosimilar of Amgen's Epogen and Janssen's Procrit. Retacrit is already in use in Europe; the product launched overseas in early 2008. Epogen/Procit/Eprex (epoetin alfa) had global sales of $3.3 billion in 2013, according to estimates by Thomson Reuters BioWorld, and is slated to lose patent protection in the United States in 2015.

Epoetin alfa, which is often used as a supportive therapy to treat chemotherapy-induced anemia, is a human erythropoietin that works by stimulating erythropoiesis and restoring red blood cell levels, decreasing the need for transfusions in patients with anemia.

The biosimilar for epoetin alfa was actually submitted to FDA on Dec. 16, 2014, but Hospira waited until 2015 to announce the submission publicly. It is Hospira’s first submission for a biosimilar in the US, according to a Hospira spokesperson.


Despite this being the first formal biosimilar submission for Hospira, it may not be the first biosimilar the company ends up launching in the US. Hospira owns the exclusive rights to market Inflectra (infliximab) through a deal with Celltrion, and this product could come to market in the US before Retacrit makes it through the regulatory process. Barring any setbacks, Celltrion said that it expects Inflectra, their biosimilar of Janssen’s Remicade (infliximab), to be approved by August 2015, even though the patent for the originator drug is set to expire at the end of 2018. Inflectra is already marketed in more than 50 countries worldwide under the brand name Remsima.

Hospira already has some successful biosimilar launches under its belt, albeit these have occurred in areas outside of the US. It is the only company based in the US that has biosimilars in use in the European market, including products such as Retacrit and Nivestem (filgrastim). Hospira’s Inflectra was the first biosimilar monoclonal antibody approved in Europe.