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.
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The US launch of Pfizer's Inflectra has been an early case study for the US biosimilar market, and some biosimilar manufacturers and payers say market access challenges are worrying.
Commissioner worries that fewer drugs may enter market in some categories because of drug development costs, and offers some post-market strategies for encouraging biosimilar development.
Pfizer filed a lawsuit against J&J over its efforts to block sales of Pfizer's biosimilar Inflectra through exclusive contracting for Remicade. The suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any Inflectra is reimbursed. J&J says Pfizer has failed to show the value of Inflectra.