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PORTLAND, Maine

Study by UNE’s 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, ’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. 

Read the study.

 

To learn more about the University of New England’s College of Pharmacy, visit www.une.edu/pharmacy

To apply, visit www.une.edu/admissions

About the University of New England

The University of New England is Maine’s largest independent university, with two beautiful coastal campuses in Maine, a one-of-a-kind study abroad campus in Tangier, Morocco, and an array of flexible, accredited online degrees. In an uncommonly welcoming and supportive community, we offer hands-on learning, empowering students to make a positive impact in a world full of challenges. The state’s top provider of health professionals, we are home to Maine’s only medical college, Maine’s only dental college, a variety of other interprofessionally aligned health care degree programs, as well as nationally recognized programs for marine science degrees, natural and social sciences degrees, arts and humanities degrees, and business degrees.