AbbVie announced Tuesday that it reached a deal with Boehringer Ingelheim to settle patent litigation, allowing the latter to launch a biosimilar version of Humira (adalimumab) in the US on July 1, 2023. "This is an important settlement as it resolves all Humira-related patent litigation in the US," remarked Laura Schumacher, chief legal officer at AbbVie.
Boehringer Ingelheim received FDA approval for its biosimilar version of Humira in 2017 under the name Cyltezo (adalimumab-adbm). However, the German drugmaker noted at the time that the product would not be launched as it was engaged in patent litigation after AbbVie sued the company the same year, alleging that Cyltezo would infringe on many of the Humira patents. Meanwhile, Boehringer Ingelheim suggested that AbbVie created a "patent thicket" to thwart competition.
Under the settlement announced Tuesday, AbbVie will grant Boehringer Ingelheim a non-exclusive license to its Humira-related intellectual property in the US. Meanwhile, Boehringer Ingelheim will make royalty payments to AbbVie. Commenting on the news, Boehringer Ingelheim US general counsel Sheila Denton stated "this resolution provides clarity regarding the availability of Cyltezo."
The settlement with Boehringer Ingelheim follows similar deals that AbbVie has reached, with the first biosimilar version of Humira set to launch in the US on January 31, 2023 as part of an agreement with Amgen. Other companies slated to launch Humira biosimilars in the US in 2023 after reaching settlements with AbbVie include Samsung Bioepis in partnership with Merck & Co., Mylan, Novartis' Sandoz unit, Pfizer and Fresenius Kabi.
Earlier this year, AbbVie announced that first-quarter sales of Humira fell 5.6 percent to about $4.5 billion due to biosimilar competition, although US sales of the treatment were up 7.1 percent to $3.2 billion.
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