Biosimilars Development Should Target “Residual Uncertainty,” FDA Says

Agency officials stress their willingness to work with applicants, while an industry expert urges comparative testing in the setting or settings most sensitive to potential differences.

FDA is willing to be flexible on biosimilar requirements to help sponsors eliminate as much “residual uncertainty” as possible, Leah Christl, associate director for biosimilars, Office of New Drugs, said during the Drug Information Association’s recent annual conference in Philadelphia.

“With your analytics, if you have products that reach that [standard of] similarity, I think your residual uncertainty is going...

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