FDA's Gottlieb: 'Pricing And Reimbursement Mischief' Holding Back Biosimilar Market

The FDA Commissioner called on payers to take steps to build the US biosimilar market and discouraged some early contracting schemes, calling them pay-for-delay tactics "dressed in the guise of rebates" in a notable speech at AHIP.

Commissioner Gottlieb speaking at RAPS 2017

FDA Commissioner Scott Gottlieb took the stage at America's Health Insurance Plans (AHIP) National Health Policy Conference March 7 with a searing message for insurers: take a more proactive role in fostering the early biosimilar market or else a "rigged" system could scare biosimilar competition out of the market altogether.

The speech was notable for the aggressive tone in which the FDA leader targeted insurers, pharmacy benefit managers and drug manufacturers that participate in what he called "pricing and rebating mischief," which he said

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