With its fourth biosimilar approval, FDA has once again shown that its thinking about how to label such products continues to evolve.
Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira
Adalimumab-atto is approved for seven indications on the reference product label but lacks four others that are protected by orphan product exclusivity; launch timing is unclear due 'patent dance' litigation.