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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Biosimilars: US FDA Expecting More Applications, Fewer Applicants
Preparing biosimilar applications still takes as much time as it would for an original BLA, FDA says.
Mylan's Fulphila Approval: Lack Of US FDA AdComm May Be A Positive For Biosimilar Industry
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.
Mylan Is First To Clear US Neulasta Biosimilar Hurdle; At-Risk Launch May Not Be Risky
Fulphila (pegfilgrastim-jmbd) to launch in US soon; Mylan overcomes complete response letter and gets approval without advisory committee review.