FDA experts unanimously endorse Amgen’s biosimilar of AbbVie’s $14B franchise drug
An FDA panel offered a clear endorsement of Amgen’s franchise-busting biosimilar of AbbVie’s $14 billion biologic Humira.
The vote was unanimous in favor of an approval on a broad slate of indications.
“I thought the voting was easy,” noted panelist Steve Solga, the chief of gastroenterology at St. Luke’s University Hospital, echoing the panel’s consensus that there could be little to argue with the FDA, particularly as more thorny issues were not covered in the discussion.
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