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First Interchangeable Humira Biosimilar Approved In US

Boehringer Ingelheim’s Cyltezo Adalimumab Rival Is Granted Second Ever FDA Designation

 
• By Dave Wallace

Boehringer Ingelheim has won a landmark first US interchangeability designation for a biosimilar to Humira, with the firm’s Cyltezo version of adalimumab representing the second ever interchangeable biosimilar approved by the FDA.

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Boehringer Ingelheim’s Cyltezo Is The First Approved Interchangeable Humira Biosimilar • Source: Alamy

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has been approved as the first US interchangeable biosimilar to Humira, and only the second interchangeable biosimilar overall, by the US Food and Drug Administration.

The biosimilar – which was initially approved by the FDA in August 2017 – is currently scheduled to be among a chasing pack of Humira biosimilars that are expected to hit the US market in 2023, after Amgen launches its Amjevita (adalimumab-atto) version at the beginning of the year, under a series of settlement deals between biosimilar sponsors and originator AbbVie

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