Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira
Company starts 'a new chapter' with the first approval out of its biosimilar pipeline, which happens to be for the biggest drug in the world.
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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.
Switching, manufacturing, and indication extrapolation among worries raised in closed-door session where AbbVie argued Humira's mechanism of action is not entirely understood.
'Amgen is speaking out of both sides of its mouth', AbbVie contends, promising suit on dozens more patents.