Hospira Submits BLA for Biosimilar in US

Hospira has submitted a biologics license application to the US Food and Drug Administration for Retacrit, a proposed biosimilar to Amgen’s Epogen (epoetin alfa) and Janssen’s Procrit (epoetin alfa).

The biosimilar application was submitted on December. 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009, The company reported on the submission in a January 12, 2015 press statement.

Hospira has several biosimilars in the European market, including Retacrit (epoetin zeta), which was launched in Europe in early 2008, and Nivestim(filgrastim), which entered the European market in 2010 and Australian market in 2011. In 2013, Hospira received European Medicines Agency approval for Inflectra (infliximab), as the first biosimilar monoclonal antibody approved in Europe.

Source: Hospira

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