AbbVie Sues Alvotech Again Alleging At-Risk Adalimumab Launch
Second Lawsuit For Infringement Under BPCIA
In the latest twist in the tussle between Alvotech and AbbVie over Humira intellectual property, the originator has sued the Icelandic firm for a second time in a court in Illinois, in an attempt to enforce almost 60 patents that it says Alvotech has previously declined to litigate.
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Alvotech has announced two studies running in parallel for the firm’s AVT04 ustekinumab biosimilar referencing Janssen’s $7.7bn Stelara treatment for autoimmune diseases, including a Phase III comparative study.
AbbVie delayed biosimilar competition to Humira “for far longer than warranted” and may have “engaged in other anti-competitive conduct to maintain its market share and pricing power” for the adalimumab brand, according to members of the US House of Representatives’ committee on oversight and reform. The US Federal Trade Commission has been urged to open a formal inquiry into the originator’s conduct.
Boehringer Ingelheim, which is looking to be among the limited players to offer an interchangeable biosimilar in the US, has reported positive switching data from the company’s “first-of-its-kind” Phase IIIb Voltaire-X study.