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Study by UNE鈥檚 Edward Li published in leading specialty pharmacy journal

Ed Li

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, 鈥19) served as a co-author of the study.

Their study is titled 鈥淎pplication of the FDA biosimilar extrapolation framework to make off-label determinations.鈥 Through the FDA鈥檚 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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