Lexology (11/05/15) Cohen, Andrew D.; Royzman, Irena

The Food and Drug Administration (FDA) has rejected an application by Hospira (now owned by Pfizer) for a biosimilar version of Amgen's Epogen (EPO). Hospira filed an abbreviated Biologics License Application in December 2014, and FDA accepted it for review in February 2015. However, FDA issued a complete response letter on Oct. 16, denying the application. The company plans to resubmit the application to FDA next year. EPO is a complex biologic that is made in engineered mammalian cells and has sugar molecules attached. The more complex the protein, the greater the potential differences from the approved product, and the more difficult it is to fully characterize those differences. Although Hospira's EPO (as Retacrit) was approved in Europe as a biosimilar of Amgen's Epogen in 2007, FDA's rejection of Hospira's proposed biosimilar suggests that a lengthy marketing history outside the United States does not necessarily guarantee U.S. approval.

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