- AbbVie's wall of patents protecting its top-selling drug Humira will keep another would-be competitor from entering the U.S. market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech.
- The deal will permit Alvotech to market its biosimilar version of Humira in the U.S. beginning on July 1, 2023, pending a Food and Drug Administration approval. AbbVie had previously sued Alvotech for patent infringement and separately alleged the biosimilar maker stole trade secrets related to Humira; the settlement resolves both disputes.
- The main patent for Humira, which treats a wide range of inflammatory diseases, expired in 2016, but other patents granted to AbbVie have prevented biosimilar makers from launching their copycat versions in the U.S. Under the settlement disclosed Tuesday, Alvotech will pay royalties for licensing Humira patents held by AbbVie.
Sales of Humira earned AbbVie $20.7 billion last year, the highest total for any pharmaceutical product excepting Pfizer and BioNTech's COVID-19 vaccine.
The bulk of that sum, some $17 billion, was made in the U.S., where Humira still benefits from patent protection. In Europe, where lower-cost biosimilar copies of Humira have been available since 2018, sales of AbbVie's drug were a comparatively much smaller $3.3 billion.
The longer market exclusivity is due to the "patent thicket" AbbVie constructed in the U.S. There, AbbVie filed 247 patent applications related to Humira, more than 100 of which were granted, according to the advocacy group I-MAK. While I-MAK acknowledges that Humira has many uses that are patentable, the group notes in its research that the number of applications far exceeds what AbbVie filed in Europe and Japan.
The extra protection those patents bought AbbVie has been extremely valuable. Between 2019 and 2021, sales of Humira totaled nearly $50 billion in the U.S., nearly five times what AbbVie earned in Europe over the same time period.
Humira's protection will run out next year, when AbbVie has negotiated licenses with 10 biosimilar developers to allow the marketing of copycat versions. The first, from Amgen, can launch beginning Jan. 31.
Expected U.S. launch dates of Humira biosimilars
|Drugmakers(s)||Biosimilar approved in US?||Expected launch date|
|Amgen||Yes, Amjevita||Jan. 31, 2023|
|Samsung Bioepis, Organon.||Yes, Hadlima||June 30, 2023|
|Boehringer Ingelheim||Yes, Cyltezo||July 1, 2023|
|Alvotech, Teva||No||July 1, 2023|
|Coherus Biosciences||Yes, Yusimry||July 1, 2023|
|Viatris||Yes, Hulio||July 31, 2023|
|Pfizer||Yes, Abrilada||"As early as" July 2023|
|Fresenius Kabi||No||Sept. 30, 2023|
|Novartis||Yes, Hyrimoz||Sept. 30, 2023|
|Momenta Pharmaceuticals||No (development discontinued||N/A; per settlement, Nov. 20, 2023|
While adoption of biosimilar drugs in the U.S. has been mostly slow in other cases, Humira could now face as many as nine copycat competitors over the course of 2023, potentially putting faster pressure on AbbVie sales.
Alvotech, which expects an FDA decision on its Humira biosimilar by December, claims its version could be a formidable competitor, as it's seeking approval for a particular formulation of Humira that now makes up much of the market. Additionally, the company aims to win what's known as "interchangeable" status, which would allow for easier substitution of the biosimilar for branded Humira.
Of the approved Humira biosimilars, only Boehringer Ingeleheim's Cyltezo is cleared as an interchangeable copy. Amgen and Pfizer also plan to secure for interchangeable status for their respective biosimilars.
Should Alvotech's drug win approval, marketing in the U.S. will be carried out by Teva Pharmaceutical Industries.
Correction: A previous version of this story referred to out-of-date launch timing for Pfizer's Abrilada.