Biosimilars: Another Untold Story of the Affordable Care Act

November 6, 2014 4:56 PM

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As the 2014 mid-term election season nears its final days, the American public has been saturated by a flood of campaign advertisements and literature attacking and promoting the Affordable Care Act (ACA). Were it not the political lightning rod that it has become, many more Americans would have a much clearer understanding about the ACA's wide breadth and how some of the law's policy changes, which are not featured in those campaign ads, will benefit them and their loved ones. In addition, a good number of these changes will significantly advance healthcare quality and science in our country.

One sweeping policy and regulatory innovation under the ACA, of which most Americans are unaware, is the role that the Food and Drug Administration (FDA) now plays in the regulation and approval of biological medicines and their biosimilar counterparts. This past summer, the first biosimilar applica...

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