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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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.
Pfizer has secured FDA approval for its adalimumab biosimilar under the name Abrilada, representing the agency’s 25th biosimilar approval overall. However, patent settlements around the Humira brand mean that Pfizer is not due to enter the market for four years.
Samsung Bioepis has become the first company to receive FDA approvals for biosimilars of all three first-generation anti-TNF biologics after gaining a nod for its Hadlima biosimilar adalimumab.