In May, FDA won approval from the Senate for a bill that will renew PDUFA (Prescription Drug User Fee Act) and increase user fees for device companies and drugmakers. Less than a week after being passed by the Senate, the bill also passed through the House of Representatives in a landslide vote of 387-5, according to an article on MedPage Today by Emily P. Walker. If the bill is put into action, previously exempt generic companies will now be liable for user fees as well. The bill should go to the President sometime in early July for final approval.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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