FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics
This article was originally published in The Pink Sheet Daily
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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New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.
Amgen’s biologic is often used off-label in healthy stem cell donors; advisory committee members distinguished between some Neupogen indications in discussing whether extrapolation was appropriate.
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.