Alvotech Heats Up Patent Dispute Conflict by Suing AbbVie Over Humira Biosimilar

Alvotech has filed a federal lawsuit against Abbvie, claiming that the pharmaceutical giant is overwhelming Alvotech with more than 60 patent claims of questionable validity to keep its high-concentration adalimumab biosimilar, AVT02 rivaling reference Humira, off the US market.

“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 unlawfully received trade secrets related to the production of AVT02.

In Alvotech’s suit, the company claimed that AbbVie has taken several inappropriate actions to develop a “patent thicket” that would deter competitors from launching adalimumab biosimilars on the market, including:

• 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, announced that the CEO of AbbVie will testify in an upcoming May 18 hearing on whether the company is using anti-competitive practices to suppress Humira competition to maintain a monopoly over the market.

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 rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis.

In 2018, AbbVie launched its citrate-free high-concentration version of adalimumab on the US market, which quickly garnered roughly 70% of the US adalimumab market share, according to HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion Healthcare.

Celltrion has also developed a high-concentration adalimumab biosimilar, which received marketing authorization in the European Union in February 2021. The high-concentration formulation is designed to be less painful upon injection and allow for more time to pass between doses.

Alvotech’s AVT02 was the first high-concentration biosimilar accepted for review by the FDA and the European Medicines Agency. The FDA is anticipated to make a decision on whether to approve the candidate in September 2021.

In January 2021, Vizient predicted in its pharmaceutical trends report that AbbVie will raise its price for adalimumab by 7.5% before biosimilar competition can enter the US market, a move that Vizient’s vice president of Pharmacy Solutions Steven Lucio, PharmD, BCPS, said is to be expected as the reference product gets closer to facing biosimilar competition in the United States.

“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.