December 15, 2017
The Journal of Managed Care and Specialty Pharmacy has published research by Edward Li, M.P.H., BCOP, professor in the College of Pharmacy. Ernesto Lobaina (COP, ’19) served as a co-author of the study.
Their study is titled “Application of the FDA biosimilar extrapolation framework to make off-label determinations.” Through the FDA’s extrapolation framework, a biosimilar can obtain licensure for indications not explicitly studied in the context of a clinical trial. This structure enables conclusions from studies in one population to make inferences in other populations.
In their manuscript, Li and Lobaina describe the FDA extrapolation framework for evaluating whether there are any differences in the mechanism of action, pharmacokinetics/biosdistribution, immunogenicity and toxicity between on-label and off-label indications. They conclude that in some cases, the use of biosimilars for off-label indications can be scientifically justified.
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