Biosimilar Draft Guidance Outlines Three-Arm Bridging Studies For Non-U.S. Products
This article was originally published in PharmAsia News
Clinical pharmacology data could help biosimilar sponsors pursue a more global development plan.
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Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
Additional draft guidances address implementation of the Drug Supply Chain Security Act, multiple endpoints in clinical trials, and public disclosure of FDA-sponsored studies.
The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.