Biosimilar Humira Settlements Stand Firm In US
Purchasers Had Alleged Anticompetitive Conduct
Settlement agreements reached by Humira biosimilar chasers Amgen, Samsung Bioepis and Sandoz in 2017 and 2018 were challenged in court by adalimumab purchasers, which alleged they formed were a part of a broader scheme to hold up competition to the multi-billion-dollar blockbuster brand in the US. But the biosimilar firms and AbbVie will not have to face the antitrust claims.
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Years before Humira rivals hit the US market in 2023, a series of litigation settlements between biosimilar adalimumab developers and originator AbbVie provided a roadmap for a succession of date-certain launches this year. Now, similar settlements over Stelara between J&J and ustekinumab developers are starting to fall into place for 2025.
Samsung Bioepis and Organon have broken new ground for Humira biosimilars in the US after receiving the first FDA approval for a higher-strength 100mg/ml adalimumab biosimilar.
Samsung Bioepis and Organon have revealed plans to compete with higher-concentration formulations of adalimumab in the US, after the FDA accepted for review an sBLA for a citrate-free 100mg/ml version of the SB5 Hadlima biosimilar that is already approved in a 50mg/ml formulation.