Biosimilars: Does FDA Caution Make Advisory Committee A Rubber Stamp?
Executive Summary
Like biosimilar candidates Zarxio and Inflectra before it, Amgen's ABP 501 enters its advisory committee review with FDA's full-throated endorsement.
You may also be interested in...
Lobbying FDA: AbbVie Questions Humira Biosimilars In Private Meeting
Switching, manufacturing, and indication extrapolation among worries raised in closed-door session where AbbVie argued Humira's mechanism of action is not entirely understood.
Lobbying FDA: AbbVie Questions Humira Biosimilars In Private Meeting
Switching, manufacturing, and indication extrapolation among worries raised in closed-door session where AbbVie argued Humira's mechanism of action is not entirely understood.
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.