FOB Security

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  • 07/20/2010

According to Craig Kessler, professor of medicine and pathology at Georgetown/Lombardi, the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness.

He said that the difference in manufacturing processes between companies can alter the drugs "in ways that technology can't detect.”

The healthcare reform law outlined a pathway for FDA to approve next-generation biopharmaceuticals modeled on original breakthrough drugs. But the legislation leaves the agency with a great deal of leeway -- including the flexibility to decide whether clinical trials are necessary at all.

"If you don't have clinical trials to take a look at all of these other off-label uses," Kessler said during a Capitol Hill discussion hosted by the Congressional Health Care Caucus, "then you don't really know what the equivalency in dosing is going to be like, and what the safety — the long-term safety — [issues] will be."

We need to proceed with biosimilars – but with care and caution.

No profit grows where is no pleasure ta’en;

In brief sir, study what you must affect

 "The Taming of the Shrew", Act 1 scene 1

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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