"Not So Different": Is It Time to Give Up on Biosimilars?

April 28, 2019

It’s no secret that the biosimilars market in the United States has been off to a sluggish start. In fact, former FDA Commissioner Scott Gottlieb, MD, went so far as to call the market anemic. While many stakeholders have called for steps like more education or greater regulatory clarity, a new option has been raised in recent weeks, and that’s doing away with the US biosimilars market altogether.

It’s no secret that the biosimilars market in the United States has been off to a sluggish start. In fact, former FDA Commissioner Scott Gottlieb, MD, went so far as to call the market anemic.

While many stakeholders have called for steps like more education or greater regulatory clarity, a new option has been raised in recent weeks, and that’s doing away with the US biosimilars market altogether.

In a 2-part proposal published on the Health Affairs Blog, a team of authors argued that efforts to induce lower prices through competition via biosimilars will inevitably fail. Instead, they write, prices for innovator biologics should be regulated by the US government after patent expiry.

This week on the podcast, we’re talking with Mark Trusheim, MS, one of the authors of the proposal. He’s a biopharmaceuticals consultant and is also the strategic director of the NEWDIGS program at the Massachusetts Institute of Technology (MIT) Center for Biomedical innovation and a visiting scientist in applied economics at MIT’s Sloan School of Management.

Read more about the proposal from Trusheim and his coauthors.


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