
Alvotech Heats Up Patent Dispute Conflict by Suing AbbVie Over Humira Biosimilar
Under the lawsuit, Alvotech alleges that AbbVie is unlawfully taking advantage of patent laws and claims courts to prevent biosimilar competition rivaling its blockbuster drug, Humira, from entering the US market.
Alvotech has
“This case aims to bring to a just end [the] defendant’s ongoing monopoly on the life-changing drug adalimumab,” Alvotech stated in its filing with the US District Court of the Eastern District of Virginia, Alexandria Division.
The news comes after AbbVie filed a separate lawsuit in March 2021, alleging that Alvotech had
In Alvotech’s suit, the company
- Patenting inventions that AbbVie does not use to produce Humira
- Seeking multiple patents on the same invention as part of different patent families to cause confusion
- Obtaining patents through unjust conduct
- Seeking patents that cover Humira already in the prior art
- Obtaining patents on inventions that AbbVie did not invent
Additionally, in April, Representative Carolyn B. Maloney, D-New York, chairwoman of the House Committee on Oversight and Reform,
Although the FDA has approved 6 adalimumab biosimilars, none can enter the US market until 2023 due to biosimilar developers settling with AbbVie instead of battling through the company’s “patent thicket” of at least 136 patents on Humira.
“AbbVie did not invent adalimumab or the subject matter of the original patents surrounding adalimumab and its use, instead acquiring them from German BASF AG. Nevertheless, despite those original patents expiring in 2016, AbbVie has been able to extend its monopoly to 2023 and beyond by deliberately seeking to block legitimate competition,” said Alvotech in a statement.
Humira is the highest sold prescription medication in the United States, accumulating more than $16 billion in domestic sales and nearly $20 billion globally in 2020, according to Alvotech. Humira is used to treat several chronic conditions, including
In 2018, AbbVie launched its citrate-free high-concentration version of adalimumab on the US market, which quickly garnered
Celltrion has also developed a high-concentration adalimumab biosimilar, which
Alvotech’s AVT02 was the first high-concentration biosimilar accepted for review by the FDA and the European Medicines Agency. The FDA is
In January 2021, Vizient predicted in its pharmaceutical trends report that AbbVie will raise its price for adalimumab
“To give AbbVie and every other manufacturer the benefit of the doubt, we do live in a time where there are cost-of-living increases and normal inflation…but not on the magnitude of what we're seeing and what we expect to see for Humira and other commonly used, high-cost medications,” said Lucio.
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