[44] Common side effects include upper respiratory tract infections, pain at the site of injection, rash, and headache.

[43] Adalimumab has been shown to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults.

[53] It has also been shown to have efficacy in moderate to severe polyarticular juvenile idiopathic arthritis in children four years and older, and is indicated for the treatment of that condition.

[55] Adalimumab has been shown to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis in children aged four years and older.

[56][57][58] Adalimumab has been shown to reduce the signs and symptoms of, and is approved for treatment for, ankylosing spondylitis in adults.

[46][67][68] Adalimumab is indicated for the treatment of non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

[69] However, such an association may reflect an increased risk of developing malignancies inherent in the conditions being treated, and not with adalimumab itself.

[71] Adalimumab was the first fully human monoclonal antibody approved by the US Food and Drug Administration (FDA).

[75] The key components of the drug were found by guiding the selection of human antibodies from phage display repertoires to a single epitope of an antigen TNF alpha.

[citation needed] Adalimumab, sold under the brand name Humira, was approved for use in the United States in 2002.

[47][83] Adalimumab, sold under the brand names Humira and Trudexa, was approved for use in the European Union in September 2003.

[43][84] The UK NHS in 2019 listed Humira, Amgevita, Hulio, Hyrimoz, Idacio, and Imraldi as biosimilars available on (almost free) prescription, to be updated in February 2022.

[7][103][104][105][106][107] In August 2017, the FDA approved German pharmaceutical company Boehringer Ingelheim's biosimilar, Cyltezo.

Adalimumab biosimilars became available in the European Union in 2018,[112] allowing the National Health Service to make record-breaking cost-savings,[113] as this is the single most expensive drug used in NHS hospitals, costing more than £400 million a year for about 46,000 patients.

[1][103][131] In January 2023, the CHMP recommended that the high-concentration 100mg/ml Hyrimoz biosimilar be granted a pan-European marketing authorization for all indications covered by the reference medicine, including Crohn's disease, plaque psoriasis, ulcerative colitis, rheumatoid arthritis and uveitis.

[2][103][134][135] Starting in July 2023, when Humira's regulatory exclusivity lapsed, a number of biosimilars such as Hadlima, Hyrimoz, Cyltezo, and Celltrion were launched in the US.

[103][139][10] In March 2003, Cambridge Antibody Technology (CAT) stated its wish to "initiate discussions regarding the applicability of the royalty offset provisions for Humira" with Abbott Laboratories in the High Court of London.

[140] In it Justice Laddie remarked, "Abbott was in error when it made its first royalty payment to CAT calculated on the basis that only 2% of the Net Sales was due.

Justice Laddie went on to observe "...that the construction advanced by Abbott does violence to the language of the agreements, renders them obscure and makes little or no commercial sense.

[146][147] In June 2020, a class action lawsuit filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie, alleging that the drug manufacturer used a patent thicket over 100 strong to maintain a monopoly on Adalimumab, was dismissed by the Northern District Court in Illinois.

[149] AbbVie has extensively used the US patent system to delay competitors from entering the market, a process commonly known as "evergreening".