FDA Chief Talks Opioid Crisis, Biosimilars

The U.S. Food and Drug Administration has the resources it needs to address the opioid crisis, commissioner Scott Gottlieb said.

"One of the things we're going to be pressing very hard on over the next year is trying to develop evidence around what the proper dispensing should be by indication," said Gottlieb, who was interviewed onstage on by Financial Times senior U.S. business correspondent David Crow at the FT U.S. Healthcare & Life Sciences Summit in New York City on Thursday, May 10.

Among the other topics discussed were biosimilars, or copies of biological products.

"I've been disappointed generally about the market as it's taking shape for biosimilars," said Gottlieb, who was sworn in as FDA chief in May of last year. 

He said the rebate structure presents a barrier to entry for biosimilars.

"One of the challenges I see is that it's very hard for a new biosimilar to penetrate the market when it does come to market in part because of the structure of the rebating system. The incumbent biosimilars have a real advantage," Gottlieb said.

Even if a new biosimilar enters the market at a discount, "if the health plan puts you on formulary, they're going to lose all the rebates on the incumbent product," he said.

In a March speech, Gottlieb said the FDA is examining its biosimilar program "to better integrate policy and review functions that can provide greater scientific and regulatory clarity for sponsors, and greater efficiencies in the review of biosimilar and interchangeable applications."

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