FDA charts path forward for biosimilars — but drug makers aren’t all on board

Stat News

30 March 2018 - In his recent public appearances, FDA Commissioner Scott Gottlieb has sounded a repeating note: drug prices are too high, and especially prices for complicated protein-based drugs called biologics.

The answer, he says, is in part encouraging generic biologics, called biosimilars, to enter the market. And one way in which the FDA can do so, Gottlieb told an assembled crowd of insurers at an industry conference earlier this month, is to set clearer standards for what these drugs have to prove to be considered equivalent — or interchangeable — to the originals.

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Michael Wonder

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Michael Wonder