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Will New FDA Commissioner Hahn Continue the Sharpless, Gottlieb Biosimilars Legacy?


On Friday, President Donald Trump announced that he intends to nominate Stephen Hahn, MD, FASTRO, to be the next FDA commissioner.

On Friday, President Donald Trump announced that he intends to nominate Stephen Hahn, MD, FASTRO, to be the next FDA commissioner.

Hahn, a radiation oncologist and cancer researcher, serves as the chief medical executive at the University of Texas MD Anderson Cancer Center, as well as a professor in the University of Texas’ department of radiation oncology. Hahn has never held a prior government position, a fact that makes his stance on a variety of issues—such as the place that biosimilars can or should hold in the US healthcare system—unclear.

Ned Sharpless, MD, who has been acting commissioner since Scott Gottlieb, MD, stepped down this spring, will return to the National Institutes of Health, where he will resume his previous role leading the National Cancer Institute. In the interim between Sharpless’ departure and Hahn’s prospective confirmation, the regulatory agency will be led by Admiral Brett Giroir, currently the Assistant Secretary for Health.

During Sharpless’ time helming the FDA, biosimilars saw several steps forward. There were 5 approvals of biosimilars—Eticovo, Kanjinti, Zirabev, Ruxience, and Hadlima—during his tenure as commissioner, as well as the release of a suite of resources intended to educate patients about biosimilars. The United States also gained its long-awaited final guidance on demonstrating interchangeability shortly after Sharpless took up the post.

The momentum biosimilars gained under Sharpless built on the work already started by Gottlieb. Throughout his own time at the FDA, Gottlieb was vocal about the importance of creating a sustainable biosimilars market in United States. In addition to releasing the Biosimilar Action Plan, he called on drug makers to “end the shenanigans” that block biosimilars, including the misuse of Risk Evaluation and Mitigation Strategy programs. He also took aim at lengthy patent litigation practices in the United States, pay-for-delay tactics, and rebate and contracting provisions, all of which he said were making the biosimilars market unstable in the United States.

But while both Gottlieb and Sharpless proved to be promoters of biosimilars, many saw Gottlieb’s outspokenness about the need for biosimilars in the US market as a major shift. In fact, James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, told The Center for Biosimilars® in an interview that Gottlieb represented “a quantum leap in terms of activism.” It remains to be seen whether Hahn’s approach to these products will continue to be an activist one, or whether the FDA under his watch will cool on biosimilars.

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