It appears that Kite Pharma Inc. received the biosimilar treatment from the US FDA in the review and approval of the drugmaker's gene therapy Yescarta (axicabtagene ciloleucel), in that only the first-in-class product received an automatic advisory committee.
Kite's Gene Therapy Yescarta Gets Biosimilar Treatment With Second-In-Class Approval
Much like it did for the first biosimilars, US FDA approved Yescarta without an advisory committee, as Novartis' first-in-class CAR-T cell therapy already set the stage for an agency review.
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