What Will Biosimilar Labeling Look Like? Stakeholders Await FDA Guidance, Approvals
Unknowns include whether labeling will include reference product’s clinical data, and how absence of data for particular indications or populations will be handled; labeling decisions for 351(k) approvals will have important ramifications for advertising and promotion of both the biosimilar and reference product.
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Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.
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.
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