The FY2014budget for FDA requests about $821M more than it received in FY2012 and part of the funding request is an additional $10M for inspections in China. Increasing foreign inspections of drug manufacturing sites will prevent unsafe drug products from entering the US. Additionally, the proposal requests the exclusivity period for brand-name biologics to decrease from 12 to 7 years in 2014, to save Medicare and Medicaid an estimated $3B over 10 years. To read more about the FY2014 budget request on in-pharmatechnologist.com, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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