US FDA's Biosimilar Advisory Committee Policy Evolves
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.
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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.
Preparing biosimilar applications still takes as much time as it would for an original BLA, FDA says.
The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.