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Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies

 
• By Nielsen Hobbs

Cyltezo won’t be available until 2023 due to patent settlement with AbbVie. The second-ever interchangeable biosimilar approved by the US FDA also contains a first: published data from a switch trial.

sunrise over Greece
WITH AN INTERCHANGABLE DESIGNATION TO Abbvie’s HUMIRA, BOEHRINGER INGELHEIM’S CYLTEZO COULD HEARLD THE DAWN OF A NEW ERA FOR BIOSIMILARS IN THE US. • Source: Alamy

Boehringer Ingelheim GmbH’s Cyltezo has won an interchangeable biosimilar designation to AbbVie Inc.’s Humira from the US Food and Drug Administration. It’s an achievement that not only heralds the likely decline of earth’s mightiest franchise, but also paves the way for many more interchangeable products since it offers the first-ever published data on what a successful switch study looks like.

FDA granted Cyltezo (adalimumab-adbm) the interchangeable designation on 15 October, but the product’s commercial license won’t begin until 1 July 2023 under a patent settlement with AbbVie related to Humira (adalimumab)

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