Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), 34 biosimilars have been approved, 23 of which have launched. Notably, since our last update, AbbVie has settled its long-running dispute with Alvotech over Alvotech’s adalimumab biosimilar—making Alvotech the 10th company to settle with AbbVie. As of this update, all companies that have an adalimumab biosimilar have settled with AbbVie. Strikingly, the number of post grant challenges against biologics patents has precipitously dropped since reaching a peak in 2017.
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