Although biosimilars, highly similar versions of living cell-based biologic medicines, have been widely available to European patients for close to a decade now, their pathway in the United States has not been equally successful. Spurred by the enactment of the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), a route for approving highly similar versions of brand name reference listed biologics became available to those companies — many from the traditional small molecule generic drug industry — that seek to compete in this higher margin and less crowded marketplace.

In this article, we will report on the recent announcement that FDA has accepted biosimilar applications for two different branded biologics, Neupogen® and Remicade®, and what that development portends, especially on the nature of the data needed to demonstrate that a biosimilar is highly similar to the branded product. We also will review the controversy over the naming of biosimilar products and highlight several recent FDA guidance documents impacting the nascent U.S. biosimilars industry.

To read the full version of the article written by Duane partner Alan Klein and special counsel Michael A. Swit, please visit the GenericsWeb website.