Boehringer Settlement Jumps The Queue For Biosimilar Adalimumab
Boehringer Ingelheim has settled litigation with AbbVie over Humira by striking a deal that allows it to launch its biosimilar adalimumab in the US from the start of July 2023.
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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.
Mylan’s Hulio has become the sixth biosimilar version of Humira to be approved by the US FDA. However, all of these adalimumab biosimilars face a wait until 2023 before they can enter the market.
The US Court of Appeals for the Federal Circuit has upheld a series of inter partes review decisions from 2017 in which three Humira patents were found invalid by the Patent Trial and Appeal Board within the US Patent and Trademark Office.