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How To Name A Biosimilar: Amgen Persisted With Amjevita Suffix Despite FDA Doubts

 
• By Sue Sutter

Drug Review Profile examines how Amgen persuaded US agency that its preferred distinguishable suffix choice for Amjevita, a biosimilar to AbbVie’s Humira, would not be confused with medical abbreviations or existing trademarks.

Amgen Inc.’s experience with Amjevita (adalimumab-atto) could serve as a case study for other biologic product sponsors hoping to get their preferred distinguishable suffix through the US FDA’s new nonproprietary name review process.

FDA initially rejected the company’s preferred suffix, “-atto,” for its biosimilar to AbbVie Inc.’s TNF-inhibitor Humira (adalimumab) because it...

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