Biosimilar Advisory Committee Reviews: Necessity Or Nuisance?
FDA panelists' confusion over biosimilarity and overwhelming approval endorsements following glowing agency reviews suggest the meetings may not be having much impact on FDA deliberations; however, agency sees an opportunity to learn from what its external experts don't understand about biosimilars.
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There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.
A departure date has yet to be determined for the associate director of therapeutic biologics, who helped negotiate and implement the biosimilar user fee program.
If first-in-class biosimilar doesn't raise new scientific issues, it may not need advisory committee meeting, FDA's Christl says in interview with the Pink Sheet, suggesting a case-by-case approach going forward.