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...