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Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira

 
• By Sue Sutter

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.

With its fourth biosimilar approval, FDA has once again shown that its thinking about how to label such products continues to evolve.

In the case of Amgen Inc.'s Amjevita (adalimumab-atto), FDA took the opportunity to adjust its biosimilar labeling approach on indications for which the reference product sponsor still holds exclusivity.

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