Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says
This article was originally published in PharmAsia News
Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.
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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.
FDA appears to be awaiting HHS clearance of its guidance, while WHO has released its proposal for public comment.
FDA clinical reviewers moved from traditional “new drug” review mode to determining the evidence needed to demonstrate a follow-on product is highly similar to the reference biologic, Sandoz exec says, describing firm’s interactions with FDA on its filgrastim 351(k) application.