adalimumab

In the US and the EU, adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.{{cite web | title=Humira- adalimumab kit Humira- adalimumab injection, solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d#section-1 | access-date=18 February 2020 | archive-date=21 June 2020 | archive-url=https://web.archive.org/web/20200621160349/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d#section-1 | url-status=live }}{{cite web | title=Imraldi- adalimumab injection, solution | website=DailyMed | date=23 January 2018 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=acdfaa71-27ed-4717-8e7d-f1a5fe0d1fa6 | access-date=18 February 2020 | archive-date=21 September 2020 | archive-url=https://web.archive.org/web/20200921060811/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=acdfaa71-27ed-4717-8e7d-f1a5fe0d1fa6 | url-status=live }} In the EU it is also indicated for chronic aggressive progressive pulmonary and bone sarcoidosis.

Adalimumab has been shown to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults. It may be used alone or in combination with disease-modifying antirheumatic drugs.{{cite journal | vauthors = Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Cruz B, Villanueva I | title = Adalimumab for treating rheumatoid arthritis | journal = The Cochrane Database of Systematic Reviews | issue = 3 | pages = CD005113 | date = July 2005 | pmid = 16034967 | doi = 10.1002/14651858.CD005113.pub2 | doi-access = }} 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. In rheumatoid arthritis, it is indicated for use alone, or with methotrexate or similar medicines, in the United States since 2002.{{cite web | vauthors = Siegel JP |publisher=U.S. Food and Drug Administration (FDA) |title=Product Approval Information - Licensing Action |access-date=4 February 2014 |url= https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm |date=31 December 2002 |archive-date=24 October 2020 |archive-url=https://web.archive.org/web/20201024195343/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm |url-status=dead }} {{PD-notice}} It has a similar effectiveness as methotrexate and, in combination, nearly doubles the response rate of methotrexate alone.{{cite journal | vauthors = Welch B |title=Adalimumab (Humira) for the Treatment of Rheumatoid Arthritis |journal=American Family Physician |volume=78 |issue=12 |date=15 December 2008 |issn=0002-838X |url=http://www.aafp.org/afp/2008/1215/p1406.html |access-date=9 September 2019 |pages=1406–1408 |archive-date=24 November 2020 |archive-url=https://web.archive.org/web/20201124103428/https://www.aafp.org/afp/2008/1215/p1406.html |url-status=live }}

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.{{cite journal | vauthors = Brunner HI, Nanda K, Toth M, Foeldvari I, Bohnsack J, Milojevic D, Rabinovich CE, Kingsbury DJ, Marzan K, Chalom E, Horneff G, Kuester RM, Dare JA, Trachana M, Jung LK, Olson J, Minden K, Quartier P, Bereswill M, Kalabic J, Kupper H, Lovell DJ, Martini A, Ruperto N | title = Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results | journal = Arthritis Care & Research | volume = 72 | issue = 10 | pages = 1420–1430 | date = October 2020 | pmid = 31421019 | pmc = 7589221 | doi = 10.1002/acr.24044 | doi-access = free }}{{cite journal | vauthors = Horneff G, Seyger MM, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS | title = Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease | journal = The Journal of Pediatrics | volume = 201 | pages = 166–175.e3 | date = October 2018 | pmid = 30054164 | doi = 10.1016/j.jpeds.2018.05.042 | doi-access = free | hdl = 2066/195625 | hdl-access = free }}{{cite journal | vauthors = Correll CK, Bullock DR, Cafferty RM, Vehe RK | title = Safety of weekly adalimumab in the treatment of juvenile idiopathic arthritis and pediatric chronic uveitis | journal = Clinical Rheumatology | volume = 37 | issue = 2 | pages = 549–553 | date = February 2018 | pmid = 29103180 | doi = 10.1007/s10067-017-3890-4 | s2cid = 20099281 }}

Adalimumab has been shown to reduce the signs and symptoms of, and is approved for treatment for, ankylosing spondylitis in adults.{{cite journal | vauthors = Maxwell LJ, Zochling J, Boonen A, Singh JA, Veras MM, Tanjong Ghogomu E, Benkhalti Jandu M, Tugwell P, Wells GA | title = TNF-alpha inhibitors for ankylosing spondylitis | journal = The Cochrane Database of Systematic Reviews | volume = 2015 | issue = 4 | pages = CD005468 | date = April 2015 | pmid = 25887212 | doi = 10.1002/14651858.CD005468.pub2 | pmc = 11200207 | url = https://figshare.com/articles/journal_contribution/TNF-alpha_inhibitors_for_ankylosing_spondylitis/22957691/1/files/40695302.pdf | access-date = 14 December 2019 | url-status = live | archive-url = https://web.archive.org/web/20240430044459/https://figshare.com/articles/journal_contribution/TNF-alpha_inhibitors_for_ankylosing_spondylitis/22957691/1/files/40695302.pdf | archive-date = 30 April 2024 }}

Adalimumab has been shown to reduce the signs and symptoms of moderate to severe Crohn's disease.{{cite journal | vauthors = Peyrin-Biroulet L, Danese S, Cummings F, Atreya R, Greveson K, Pieper B, Kang T | title = Anti-TNF biosimilars in Crohn's Disease: a patient-centric interdisciplinary approach | journal = Expert Review of Gastroenterology & Hepatology | volume = 13 | issue = 8 | pages = 731–738 | date = August 2019 | pmid = 31322440 | doi = 10.1080/17474124.2019.1645595 | doi-access = free }}{{cite journal | vauthors = Podolsky DK | title = Inflammatory bowel disease | journal = The New England Journal of Medicine | volume = 347 | issue = 6 | pages = 417–429 | date = August 2002 | pmid = 12167685 | doi = 10.1056/NEJMra020831 | url = https://gut.bmj.com/content/gutjnl/39/Suppl_1/A15.full.pdf | access-date = 24 September 2019 | url-status = unfit | archive-url = https://web.archive.org/web/20200314042731/https://gut.bmj.com/content/gutjnl/39/Suppl_1/A15.full.pdf | archive-date = 14 March 2020 }}{{cite journal | vauthors = Gearry RB, Frampton C, Inns S, Poppelwell D, Rademaker M, Suppiah R | title = VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand | journal = Current Medical Research and Opinion | volume = 35 | issue = 10 | pages = 1837–1846 | date = October 2019 | pmid = 31233347 | doi = 10.1080/03007995.2019.1634952 | s2cid = 195354397 }} It has been approved for that use in the UK since 2009.{{cite web | vauthors = Morey S | title = UK – Summary of NICE Approvals in September 2009 | date = 17 September 2009 | access-date = 4 February 2014 | url = https://worldpharmaoutlook.blogspot.com/2009/09/uk-summary-of-nice-approvals-in.html | archive-date = 20 September 2018 | archive-url = https://web.archive.org/web/20180920115308/http://worldpharmaoutlook.blogspot.com/2009/09/uk-summary-of-nice-approvals-in.html | url-status = live }}

Adalimumab may be effective and well tolerated in ulcerative colitis. It was approved by the US Food and Drug Administration (FDA) for treatment of moderate to severe cases in adults.{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321650.htm |title=FDA approves Humira to treat ulcerative colitis |date=28 September 2012 |publisher=U.S. Food and Drug Administration (FDA) | archive-url=https://web.archive.org/web/20120930235859/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321650.htm |archive-date=30 September 2012| url-status=dead }} {{PD-notice}}{{cite press release | title=Abbott's Humira (adalimumab) Receives U.S. FDA Approval for the Treatment of Adult Patients with Moderate to Severe Ulcerative Colitis | website=Abbott | date=28 September 2012 | url=https://abbott.mediaroom.com/2012-09-28-Abbotts-HUMIRA-adalimumab-Receives-U-S-FDA-Approval-for-the-Treatment-of-Adult-Patients-with-Moderate-to-Severe-Ulcerative-Colitis | archive-url=https://web.archive.org/web/20191119023917/https://abbott.mediaroom.com/2012-09-28-Abbotts-HUMIRA-adalimumab-Receives-U-S-FDA-Approval-for-the-Treatment-of-Adult-Patients-with-Moderate-to-Severe-Ulcerative-Colitis | archive-date=19 November 2019 | url-status=live | access-date=18 November 2019}}

Adalimumab has been shown to treat moderate to severe chronic plaque psoriasis in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).{{cite journal | vauthors = Croom KF, McCormack PL | title = Adalimumab: in plaque psoriasis | journal = American Journal of Clinical Dermatology | volume = 10 | issue = 1 | pages = 43–50 | year = 2009 | pmid = 19170412 | doi = 10.2165/0128071-200910010-00008 }} Adalimumab has been shown to be effective therapy when used either continuously or intermittently in patients with moderate to severe psoriasis.{{cite journal | vauthors = Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG, Strober BE, Kaul M, Gu Y, Okun M, Papp K | title = Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial | journal = Journal of the American Academy of Dermatology | volume = 58 | issue = 1 | pages = 106–115 | date = January 2008 | pmid = 17936411 | doi = 10.1016/j.jaad.2007.09.010 }}

Adalimumab was approved for hidradenitis suppurativa in 2015.{{cite web|title=FDA Clears Adalimumab (Humira) for Hidradenitis Suppurativa | vauthors = Megan B |url=https://www.medscape.com/viewarticle/850897|date=11 September 2015|access-date=13 October 2017|publisher=Medscape|archive-date=21 January 2021|archive-url=https://web.archive.org/web/20210121031028/https://www.medscape.com/viewarticle/850897|url-status=live}}{{cite journal | vauthors = Gulliver W, Zouboulis CC, Prens E, Jemec GB, Tzellos T | title = Evidence-based approach to the treatment of hidradenitis suppurativa/acne inversa, based on the European guidelines for hidradenitis suppurativa | journal = Reviews in Endocrine & Metabolic Disorders | volume = 17 | issue = 3 | pages = 343–351 | date = September 2016 | pmid = 26831295 | pmc = 5156664 | doi = 10.1007/s11154-016-9328-5 }}{{cite journal | vauthors = Maarouf M, Clark AK, Lee DE, Shi VY | title = Targeted treatments for hidradenitis suppurativa: a review of the current literature and ongoing clinical trials | journal = The Journal of Dermatological Treatment | volume = 29 | issue = 5 | pages = 441–449 | date = August 2018 | pmid = 29098911 | doi = 10.1080/09546634.2017.1395806 | s2cid = 39246564 }}

Adalimumab is indicated for the treatment of non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).

Adalimumab is a monoclonal antibody. It works by binding to and inhibiting Tumor necrosis factor alpha (TNF-alpha) and inducing apoptosis in mononuclear cells expressing TNF.{{cite journal | vauthors = Vena GA, Cassano N | title = Drug focus: adalimumab in the treatment of moderate to severe psoriasis | journal = Biologics | volume = 1 | issue = 2 | pages = 93–103 | date = June 2007 | pmid = 19707319 | pmc = 2721299 }}

The US FDA label contains a boxed warning about serious infections and malignancies.

There is strong evidence that adalimumab increases risk of serious infections, such as tuberculosis, and it has also been reported to increase the risk of developing various cancers.{{cite journal | vauthors = Hochman D, Wolff B | title = Risk of serious infections and malignancies with anti-TNF antibody therapy in rheumatoid arthritis | journal = JAMA | volume = 296 | issue = 18 | pages = 2203; author reply 2203-2203; author reply 2204 | date = November 2006 | pmid = 17090763 | doi = 10.1001/jama.296.18.2203-a }} However, such an association may reflect an increased risk of developing malignancies inherent in the conditions being treated, and not with adalimumab itself. A systematic review published in 2018, found no increased cancer incidence rate in patients with chronic inflammatory disorders treated with adalimumab and other TNF inhibitors, as compared to those who were not, with a possible exception for non-melanoma skin cancer.{{cite journal | vauthors = Chen Y, Friedman M, Liu G, Deodhar A, Chu CQ | title = Do tumor necrosis factor inhibitors increase cancer risk in patients with chronic immune-mediated inflammatory disorders? | journal = Cytokine | volume = 101 | pages = 78–88 | date = January 2018 | pmid = 27688201 | doi = 10.1016/j.cyto.2016.09.013 | s2cid = 20837188 }}

Injection site reactions such as redness and pain are very common, and may occur in up to 80% of cases.{{cite journal | vauthors = Yoshida T, Otaki Y, Katsuyama N, Seki M, Kubota J | title = New adalimumab formulation associated with less injection site pain and improved motivation for treatment | journal = Modern Rheumatology | volume = 29 | issue = 6 | pages = 949–953 | date = November 2019 | pmid = 30183438 | doi = 10.1080/14397595.2018.1520426 | s2cid = 52160836 }}

Adalimumab was the first fully human monoclonal antibody approved by the US Food and Drug Administration (FDA).{{cite journal | vauthors = Frenzel A, Schirrmann T, Hust M | title = Phage display-derived human antibodies in clinical development and therapy | journal = mAbs | volume = 8 | issue = 7 | pages = 1177–1194 | date = October 2016 | pmid = 27416017 | pmc = 5058633 | doi = 10.1080/19420862.2016.1212149 | doi-access = free }} It is derived from phage display.{{cite journal | vauthors = Brekke OH, Sandlie I | title = Therapeutic antibodies for human diseases at the dawn of the twenty-first century | journal = Nature Reviews. Drug Discovery | volume = 2 | issue = 1 | pages = 52–62 | date = January 2003 | pmid = 12509759 | doi = 10.1038/nrd984 | s2cid = 3181573 }}

Adalimumab was discovered as a result of a collaboration between BASF Bioresearch Corporation and Cambridge Antibody Technology, U.K., itself a collaboration of the government-funded Medical Research Council and three academics, which began in 1993.{{cite journal | vauthors = McCafferty J | title = The long and winding road to antibody therapeutics | journal = mAbs | volume = 2 | issue = 5 | pages = 459–460 | year = 2010 | pmid = 20978369 | pmc = 2958567 | doi = 10.4161/mabs.2.5.13088 }}

Initially named D2E7,{{cite journal | vauthors = Kempeni J | title = Preliminary results of early clinical trials with the fully human anti-TNFalpha monoclonal antibody D2E7 | journal = Annals of the Rheumatic Diseases | volume = 58 | issue = Suppl 1 | pages = I70–I72 | date = November 1999 | pmid = 10577977 | pmc = 1766582 | doi = 10.1136/ard.58.2008.i70 }} it was then further manufactured at BASF Bioresearch Corporation, developed by BASF Knoll (BASF Pharma), and ultimately manufactured and marketed by Abbott Laboratories after Abbott's acquisition of BASF Pharma. On 1 January 2013, Abbott split into two companies, one retaining the Abbott name and the other named AbbVie.{{cite press release|url=https://www.abbottinvestor.com/news-releases/news-release-details/abbott-completes-separation-research-based-pharmaceuticals/|title=Abbott Completes Separation Of Research-Based Pharmaceuticals Business|publisher=Abbott Laboratories|access-date=9 September 2019|archive-date=8 August 2020|archive-url=https://web.archive.org/web/20200808004335/https://www.abbottinvestor.com/news-releases/news-release-details/abbott-completes-separation-research-based-pharmaceuticals/|url-status=live}} As a result, AbbVie took over development and marketing of Humira.{{cite web | vauthors = Turner S | title=Humira: the highs and lows of the world's most successful drug | website=Pharmaceutical Technology | date=5 September 2018 | url=https://www.pharmaceutical-technology.com/features/humira-abbvie-drug/ | access-date=9 September 2019 | archive-date=9 September 2019 | archive-url=https://web.archive.org/web/20190909132529/https://www.pharmaceutical-technology.com/features/humira-abbvie-drug/ | url-status=live }}{{cite web | vauthors = Japsen B | title=Why Abbvie May Have A Tough Time Defending Humira's Price Before Congress | website=Forbes | date=26 February 2019 | url=https://www.forbes.com/sites/brucejapsen/2019/02/26/why-abbvie-may-have-a-tough-time-defending-humiras-price-before-congress/ | access-date=9 September 2019 | archive-date=27 February 2019 | archive-url=https://web.archive.org/web/20190227134221/https://www.forbes.com/sites/brucejapsen/2019/02/26/why-abbvie-may-have-a-tough-time-defending-humiras-price-before-congress/ | url-status=live }} The brand name Humira stands for "human monoclonal antibody in rheumatoid arthritis", and was named by one of Abbott's employees, Richard J. Karwoski, who was also responsible for leading the effort to get Humira approved by the FDA.

It is the third TNF inhibitor, after infliximab and etanercept, to be approved in the United States. It is constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody{{cite web | title=Remicade- infliximab injection, powder, lyophilized, for solution | website=DailyMed | date=8 April 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257 | access-date=22 May 2024}} and etanercept is a TNF receptor-IgG fusion protein.{{cite web | title=Enbrel- etanercept solution Enbrel- etanercept kit | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f | access-date=17 April 2021}}

The drug candidate was discovered initially using CAT's phage display technology and named D2E7. 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.{{cite journal | vauthors = Jespers LS, Roberts A, Mahler SM, Winter G, Hoogenboom HR | title = Guiding the selection of human antibodies from phage display repertoires to a single epitope of an antigen | journal = Bio/Technology | volume = 12 | issue = 9 | pages = 899–903 | date = September 1994 | pmid = 7521646 | doi = 10.1038/nbt0994-899 | s2cid = 6096492 }} The ultimate clinical candidate, D2E7, was created and manufactured at BASF Bioresearch Corporation and taken through most of the drug development process by BASF Knoll, then further development, manufacturing and marketing by Abbott Laboratories, after Abbott acquired the pharmaceutical arm of BASF Knoll.{{cite press release |url=http://www2.basf.us/corporate/news2000/newsknoll_pharma_121500.html |title=BASF to focus more strongly on innovative chemistry, a highly efficient Verbund and a global presence |access-date=9 December 2012 |url-status=dead |archive-url=https://web.archive.org/web/20130212013858/http://www2.basf.us/corporate/news2000/newsknoll_pharma_121500.html |archive-date=12 February 2013 }}

Since 2008, adalimumab had been approved by the FDA for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Although only approved for ulcerative colitis from late 2012, by the FDA in the disease's management, it had been used for several years in cases that have not responded to conventional treatment at standard dosing for Crohn's disease.{{citation needed|date=September 2019}}

Adalimumab, sold under the brand name Humira, was approved for use in the United States in 2002.{{cite web | title=Drug Approval Package: Humira (adalimumab) | publisher=U.S. Food and Drug Administration (FDA) | date=7 April 2017 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.cfm | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218175026/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.cfm | url-status=live }}{{cite web | title=Humira: FDA-Approved Drugs | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125057 | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218175336/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125057 | url-status=live }}

Adalimumab, sold under the brand names Humira and Trudexa, was approved for use in the European Union in September 2003.{{cite web | title=Humira EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/humira | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218190451/https://www.ema.europa.eu/en/medicines/human/EPAR/humira | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.{{cite web | title=Trudexa EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218190523/https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa | url-status=live }}

• 1999: Preliminary results of early clinical trials with the fully human anti-TNFα monoclonal antibody D2E7
• 2001, June: Results from ARMADA, a double-blind, placebo-controlled clinical trial involving 271 patients with active rheumatoid arthritis despite treatment with methotrexate are announced. Results show that 50% of patients demonstrate a 50% improvement in American College of Rheumatology (ACR) score.{{cite press release |url=https://www.abbottinvestor.com/news-releases/news-release-details/abbott-laboratories-investigational-fully-human-anti-tnf-therapy |title=Abbott Laboratories' Investigational Fully Human Anti-Tnf Therapy, D2E7 (Adalimumab), Shows Promise In Reducing The Signs And Symptoms Of Rheumatoid Arthritis |date=12 November 2001 |access-date=9 September 2019 |archive-date=4 December 2019 |archive-url=https://web.archive.org/web/20191204030049/https://www.abbottinvestor.com/news-releases/news-release-details/abbott-laboratories-investigational-fully-human-anti-tnf-therapy |url-status=live }}
• 2002: Broke ground on a new biologics manufacturing facility.{{cite web|url=http://truecostofhealthcare.org/wp-content/uploads/2015/01/Abbott_Report_2006.87103312.pdf |title=Abbott 2006 Annual Report |publisher=Abbott |access-date=27 July 2009 |url-status=live |archive-url=https://web.archive.org/web/20080113230332/http://www.abbott.com/static/content/microsite/annual_report/2006/humira.html |archive-date=13 January 2008 }}
• 2002: Adalimumab results from five separate trials show that it is effective at reducing signs and symptoms of rheumatoid arthritis and had a rapid onset of action and sustained efficacy. Adalimumab was safe and effective when given alone or in combination with MTX as a subcutaneous injection.{{cite journal | vauthors = Rau R | title = Adalimumab (a fully human anti-tumour necrosis factor alpha monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials | journal = Annals of the Rheumatic Diseases | volume = 61 | issue = Suppl 2 | pages = ii70–ii73 | date = November 2002 | pmid = 12379628 | pmc = 1766697 | doi = 10.1136/ard.61.suppl_2.ii70 }}
• 2002: Humira approved by the US Food and Drug Administration (FDA) for treatment of rheumatoid arthritis.
• 2003: Launched Humira for rheumatoid arthritis and continued clinical studies for additional indications.
• 2005: Launched Humira for psoriatic arthritis. Exceeded {{US$|1{{nbsp}}billion}} in annual sales for the first time.
• 2005: Eisai submits new drug application for adalimumab (D2E7) in Japan.{{cite web|url=http://www.thefreelibrary.com/Eisai+Submits+New+Drug+Application+for+Rheumatoid+Arthritis+Drug...-a0140148456|title=Eisai Submits New Drug Application for Rheumatoid Arthritis Drug Adalimumab (D2E7) in Japan.|work=thefreelibrary.com|access-date=27 July 2009|archive-date=13 October 2012|archive-url=https://web.archive.org/web/20121013055147/http://www.thefreelibrary.com/Eisai+Submits+New+Drug+Application+for+Rheumatoid+Arthritis+Drug...-a0140148456|url-status=live}}
• 2006: Submitted Humira for the Crohn's disease indication and launched it for AS. Exceeded {{US$|2{{nbsp}}billion}} in annual sales.
• 2007: Launched Humira for Crohn's disease in the United States, submitted Humira for global regulatory approval for psoriasis — the fifth Humira disease indication, achieved more than {{US$|3{{nbsp}}billion}} in worldwide Humira sales.{{cite web|url=http://truecostofhealthcare.org/wp-content/uploads/2015/01/Abbott_Report_2007.87102217.pdf |title=Abbott 2007 Annual Report |publisher=Abbott |access-date=27 July 2009 |url-status=live |archive-url=https://web.archive.org/web/20090503120558/http://www.abbott.com/static/content/microsite/annual_report/2007/overview_milestones.html |archive-date=3 May 2009 }}
• 2007: Abbott opens new biotechnology manufacturing facility in Puerto Rico{{cite press release|url=https://www.abbottinvestor.com/news-releases/news-release-details/abbott-opens-new-biotechnology-manufacturing-facility-puerto/ |title=Abbott Opens New Biotechnology Manufacturing Facility In Puerto Rico |date=10 April 2007 |publisher=Abbott |access-date=27 July 2009 |url-status=live |archive-url=https://web.archive.org/web/20090530074305/http://www.abbott.com/global/url/pressRelease/en_US/60.5%3A5/Press_Release_0439.htm |archive-date=30 May 2009 }}
• 2008: Launched Humira for plaque psoriasis{{cite press release | title=Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis | publisher=Abbott Laboratories | date=18 January 2008 | url=https://www.abbottinvestor.com/news-releases/news-release-details/abbotts-humirar-adalimumab-receives-fda-approval-moderate-severe | access-date=9 September 2019 | archive-date=7 August 2020 | archive-url=https://web.archive.org/web/20200807232141/https://www.abbottinvestor.com/news-releases/news-release-details/abbotts-humirar-adalimumab-receives-fda-approval-moderate-severe | url-status=live }}
• 2009: Five-Year data demonstrate initial use of humira plus methotrexate may prevent further joint damage in early rheumatoid arthritis patients {{cite press release|url=http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0737.htm |title=Five-Year Data Demonstrate Initial Use Of Abbott's Humira (Adalimumab) Plus Methotrexate May Prevent Further Joint Damage In Early Rheumatoid Arthritis Patients |publisher=Abbott |access-date=27 July 2009 |url-status=dead |archive-url=https://web.archive.org/web/20100322234901/http://www.abbott.com/global/url/pressRelease/en_US/60.5%3A5/Press_Release_0737.htm |archive-date=22 March 2010 }}{{cite journal | vauthors = Papagoras C, Voulgari PV, Drosos AA | title = Long-term use of adalimumab in the treatment of rheumatic diseases | journal = Open Access Rheumatology: Research and Reviews| volume = 1 | pages = 51–68 | year = 2009 | pmid = 27789981 | pmc = 5074727 | doi = 10.2147/oarrr.s4297 | doi-access = free }}
• 2012: Humira could be associated with a significant decrease in vascular inflammation, a major risk factor of cardiovascular disease{{cite web|url=https://www.sciencedaily.com/releases/2012/03/120316101632.htm|title=Treating psoriasis to prevent heart attacks and strokes|website=ScienceDaily|access-date=9 March 2018|archive-date=20 September 2018|archive-url=https://web.archive.org/web/20180920121300/https://www.sciencedaily.com/releases/2012/03/120316101632.htm|url-status=live}}
• 2013: Because of the split of Abbott, Humira rights are now owned by AbbVie.
• 2014: Humira recognized by IMS Health as the "world's best selling drug".{{cite news | url=http://www.dddmag.com/news/2014/07/humira-lifts-abbvie-28-q2 | title=Humira Lifts AbbVie 2.8% in Q2 | work=Discovery and Development | date=25 July 2014 | agency=Associated Press | access-date=27 July 2014 | archive-url=https://web.archive.org/web/20140727000006/http://www.dddmag.com/news/2014/07/humira-lifts-abbvie-28-q2 | archive-date=27 July 2014 | url-status=dead }}
• 2014: In December 2014, Indian drugmaker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its US price. The generic was launched under the brand name Exemptia.
• 2015: Launched Humira for moderate to severe hidradenitis suppurativa, an orphan indication. No other treatment has been{{when|date=November 2019}} rigorously tested and found to be safe and effective in treating this condition.

{{update section|date=February 2023}}

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.{{cite web |title=Adalimumab (Humira) and its biosimilars: medicine used for joint pain and inflammation | website=NHS (UK) |date=18 February 2019 |url=https://www.nhs.uk/medicines/adalimumab/ |access-date=3 January 2022 |archive-date=3 January 2022 |archive-url=https://web.archive.org/web/20220103154302/https://www.nhs.uk/medicines/adalimumab/ |url-status=live }} The annual cost of adalimumab, the costliest NHS drug, was expected to drop from £400m to £100m by 2021, the biggest saving in NHS history from a single drug negotiation.{{cite web |title=NHS set to save record £300 million on the NHS's highest drug spend | website=NHS England |date=26 November 2018 |url=https://www.england.nhs.uk/2018/11/nhs-set-to-save-record-300-million-on-the-nhss-highest-drug-spend/ |access-date=3 January 2022 |archive-date=3 January 2022 |archive-url=https://web.archive.org/web/20220103174136/https://www.england.nhs.uk/2018/11/nhs-set-to-save-record-300-million-on-the-nhss-highest-drug-spend/ |url-status=live }}

The best-selling drugs list published by Genetic Engineering & Biotechnology News, shows that Humira occupied the {{No.|1}} position for 2015 ({{US$|14.012{{nbsp}}billion}}) and 2016 ({{US$|16.078{{nbsp}}billion}}){{cite web| vauthors = Philippidis A |url=https://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868|title=The Top 15 Best-Selling Drugs of 2016|website=Genengnews.com|date=6 March 2017|access-date=8 March 2018|archive-date=8 March 2018|archive-url=https://web.archive.org/web/20180308232525/https://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868|url-status=live}} From 2012 until the US patent expired in 2016, Humira led the list of top-selling pharmaceutical products, and in 2016, it had {{US$|16{{nbsp}}billion}} of global sales. AbbVie reported that Humira achieved {{US$|18.427{{nbsp}}billion}} of sales in 2017.{{cite press release|url=https://news.abbvie.com/news/abbvie-reports-full-year-and-fourth-quarter-2017-financial-results.htm|title=AbbVie Reports Full-Year and Fourth-Quarter 2017 Financial Results|website=AbbVie|access-date=8 March 2018|archive-date=12 April 2018|archive-url=https://web.archive.org/web/20180412224817/https://news.abbvie.com/news/abbvie-reports-full-year-and-fourth-quarter-2017-financial-results.htm|url-status=live}} Humira had the largest worldwide drug sales in 2019 and 2020 of US$19.7bn and US$20.4bn respectively.{{cite journal | vauthors = Urquhart L | title = Top companies and drugs by sales in 2020 | journal = Nature Reviews. Drug Discovery | volume = 20 | issue = 4 | pages = 253 | date = April 2021 | pmid = 33727694 | doi = 10.1038/d41573-021-00050-6 | s2cid = 232262026 }}

{{see also|Biosimilars}}

From 2014, biosimilars were manufactured by several companies and sold at a lower price than before patent expiry.{{cite news |title=India's Cadila launches first cheaper copy of world's top-selling drug |url=https://www.reuters.com/article/us-cadila-health-humira-india/indias-cadila-launches-first-cheaper-copy-of-worlds-top-selling-drug-idUSKBN0JN0X820141209 |work=Reuters |date=9 December 2014 |access-date=19 March 2019 |archive-date=27 March 2019 |archive-url=https://web.archive.org/web/20190327092115/https://www.reuters.com/article/us-cadila-health-humira-india/indias-cadila-launches-first-cheaper-copy-of-worlds-top-selling-drug-idUSKBN0JN0X820141209 |url-status=live }}

In 2014, Indian drugmaker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its US price. The generic was launched under the brand name Exemptia. In 2016, Indian drugmaker Torrent Pharmaceuticals launched its biosimilar for adalimumab, called Adfrar. It is the second generic biosimilar of adalimumab.{{cite news|url=http://www.business-standard.com/article/companies/torrent-launches-world-s-second-biosimilar-of-generic-auto-immune-drug-116011100615_1.html|title=Torrent launches world's second biosimilar of generic auto-immune drug|date=11 January 2016|newspaper=Business Standard|access-date=1 March 2016|archive-date=26 February 2016|archive-url=https://web.archive.org/web/20160226122119/http://www.business-standard.com/article/companies/torrent-launches-world-s-second-biosimilar-of-generic-auto-immune-drug-116011100615_1.html|url-status=live}}

In September 2016, the FDA approved Amgen's biosimilar adalimumab-atto, sold under the brand name Amjevita.{{cite web | title=Amjevita- adalimumab-atto injection | website=DailyMed | date=11 April 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c44bd5b-4464-40a4-8933-8680950f00f2 | access-date=25 June 2023 | archive-date=26 June 2023 | archive-url=https://web.archive.org/web/20230626033841/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c44bd5b-4464-40a4-8933-8680950f00f2 | url-status=live }}{{cite web | title=Amjevita- adalimumab-atto injection | website=DailyMed | date=11 April 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7178e36-6787-45ab-8fee-be59bc6a4aa4 | access-date=25 June 2023 | archive-date=26 June 2023 | archive-url=https://web.archive.org/web/20230626033840/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7178e36-6787-45ab-8fee-be59bc6a4aa4 | url-status=live }}{{cite web | title=Drug Approval Package: Amjevita (adalimumab-atto) | publisher=U.S. Food and Drug Administration (FDA) | date=9 November 2016 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm | access-date=11 February 2020 | archive-date=4 October 2020 | archive-url=https://web.archive.org/web/20201004023112/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm | url-status=live }}{{cite press release | title=FDA approves Amjevita, a biosimilar to Humira | publisher=U.S. Food and Drug Administration (FDA) | date=23 September 2016 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira | archive-url=https://web.archive.org/web/20191119015605/https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira | archive-date=19 November 2019 | url-status=dead | access-date=18 November 2019}} {{PD-notice}}{{cite web | title=Amjevita: FDA-Approved Drugs | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761024 | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218192306/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761024 | url-status=dead }}

In August 2017, the FDA approved German pharmaceutical company Boehringer Ingelheim's biosimilar, Cyltezo.{{cite web | title=CYLTEZO- adalimumab-adbm kit | website=DailyMed | date=12 July 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=115ea79b-7209-7f19-b35d-36ec0828fbf5 | access-date=6 October 2023 | archive-date=6 October 2023 | archive-url=https://web.archive.org/web/20231006192824/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=115ea79b-7209-7f19-b35d-36ec0828fbf5 | url-status=live }}{{cite web | title=Drug Approval Package: Cyltezo (adalimumab-adbm) | publisher=U.S. Food and Drug Administration (FDA) | date=27 September 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761058Orig1s000TOC.cfm | access-date=11 February 2020 | archive-date=4 October 2020 | archive-url=https://web.archive.org/web/20201004013741/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761058Orig1s000TOC.cfm | url-status=live }}{{cite web | title=FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira | publisher=U.S. Food and Drug Administration | date=18 October 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira | access-date=11 February 2023 | archive-date=21 October 2021 | archive-url=https://web.archive.org/web/20211021173522/https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira | url-status=dead }}{{cite web | title=Cyltezo: FDA-Approved Drugs | publisher=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058 | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218192541/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058 | url-status=live }}{{cite press release|url=https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-pharmaceuticals-inc-receives-fda-approval-cyltezo-adalimumab|title=Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of multiple chronic inflammatory diseases|date=29 August 2017|access-date=19 March 2019|publisher=Boehringer Ingelheim Pharmaceuticals|archive-date=24 July 2019|archive-url=https://web.archive.org/web/20190724050852/https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-pharmaceuticals-inc-receives-fda-approval-cyltezo-adalimumab|url-status=live}}

In 2017, the biosimilars Amgevita,{{cite web | title=Amgevita EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita | access-date=18 February 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230161340/https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita | url-status=live }} Solymbic,{{cite web | title=Solymbic EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic | access-date=18 February 2020 | archive-date=25 June 2019 | archive-url=https://web.archive.org/web/20190625133941/https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic | url-status=live }} Imraldi,{{cite web | title=Imraldi EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi | access-date=18 February 2020 | archive-date=24 March 2020 | archive-url=https://web.archive.org/web/20200324045318/https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi | url-status=live }} and Cyltezo{{cite web | title=Cyltezo EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo | access-date=18 February 2020 | archive-date=6 August 2020 | archive-url=https://web.archive.org/web/20200806180247/https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo | url-status=live }} were approved for use in the European Union.

In 2018, the biosimilars Halimatoz,{{cite web | title=Halimatoz EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz | access-date=18 February 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230161739/https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz | url-status=live }} Hefiya,{{cite web | title=Hefiya EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya | access-date=18 February 2020 | archive-date=15 October 2019 | archive-url=https://web.archive.org/web/20191015195616/https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya | url-status=live }} Hyrimoz,{{cite web | title=Hyrimoz EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz | access-date=18 February 2020 | archive-date=16 November 2019 | archive-url=https://web.archive.org/web/20191116205930/https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz | url-status=live }} and Hulio{{cite web | title=Hulio EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hulio | access-date=18 February 2020 | archive-date=24 March 2020 | archive-url=https://web.archive.org/web/20200324055630/https://www.ema.europa.eu/en/medicines/human/EPAR/hulio | url-status=live }} were approved for use in the European Union.

Adalimumab biosimilars became available in the European Union in 2018,{{cite web|url=https://www.biopharma-reporter.com/Article/2018/10/16/First-wave-of-Humira-biosimilars-enters-EU-market|title=First wave of Humira biosimilars enters EU market| vauthors = Hargreaves B |website=BioPharma-Reporter|date=16 October 2018|access-date=26 November 2018|archive-date=15 August 2020|archive-url=https://web.archive.org/web/20200815015346/https://www.biopharma-reporter.com/Article/2018/10/16/First-wave-of-Humira-biosimilars-enters-EU-market|url-status=live}} allowing the National Health Service to make record-breaking cost-savings,{{cite news|url=https://www.theguardian.com/society/2018/nov/26/nhs-replaces-highest-spend-drug-with-300m-cheaper-alternative|title=NHS replaces highest-spend drug with £300m cheaper alternative| vauthors = Heal A |date=26 November 2018|newspaper=The Guardian|access-date=26 November 2018|archive-date=26 November 2018|archive-url=https://web.archive.org/web/20181126003712/https://www.theguardian.com/society/2018/nov/26/nhs-replaces-highest-spend-drug-with-300m-cheaper-alternative|url-status=live}} as this is the single most expensive drug used in NHS hospitals, costing more than £400{{nbsp}}million a year for about 46,000 patients.{{cite news | vauthors = Dent E |title=Most expensive NHS drug comes off patent |url=https://pharmaceutical-journal.com/article/news/most-expensive-nhs-drug-comes-off-patent |access-date=29 November 2018 |publisher=Pharmaceutical Journal |date=18 October 2018 |archive-date=18 May 2021 |archive-url=https://web.archive.org/web/20210518134446/https://pharmaceutical-journal.com/article/news/most-expensive-nhs-drug-comes-off-patent |url-status=live }}

In October 2018, adalimumab-adaz (Hyrimoz) was approved for use in the United States.{{cite web | title=Hyrimoz: FDA-Approved Drugs | publisher=U.S. Food and Drug Administration (FDA) | date=30 October 2018 | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761071 | archive-url=https://web.archive.org/web/20191207062533/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761071 | archive-date=7 December 2019 | url-status=dead | access-date=6 December 2019}} {{PD-notice}}{{cite web | title=Drug Approval Package: Hyrimoz | publisher=U.S. Food and Drug Administration (FDA) | date=21 March 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm | access-date=11 February 2020 | archive-date=18 December 2019 | archive-url=https://web.archive.org/web/20191218044943/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm | url-status=live }}

In April 2019, Idacio{{cite web | title=Idacio EPAR | website=European Medicines Agency (EMA) | date=29 January 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/idacio | access-date=18 February 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230161513/https://www.ema.europa.eu/en/medicines/human/EPAR/idacio | url-status=live }} and Kromeya{{cite web | title=Kromeya EPAR | website=European Medicines Agency (EMA) | date=29 January 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya | access-date=18 February 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230161654/https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya | url-status=live }} were approved for use in the European Union.

In July 2019, adalimumab-bwwd (Hadlima), produced by Samsung Bioepsis, was approved for use in the US.{{cite web | title=Hadlima- adalimumab-bwwd solution | website=DailyMed | date=11 July 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4774a951-3ce8-43b6-80b1-e6b23752aae6 | access-date=6 October 2023 | archive-date=6 October 2023 | archive-url=https://web.archive.org/web/20231006192824/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4774a951-3ce8-43b6-80b1-e6b23752aae6 | url-status=live }}{{cite web|url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761059|publisher=U.S. Food and Drug Administration (FDA)|title=Hadlima: FDA-Approved Drugs|access-date=8 November 2019|archive-date=19 October 2020|archive-url=https://web.archive.org/web/20201019031907/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761059|url-status=live}} {{PD-notice}}{{cite web | title=Drug Approval Package: Hadlima | publisher=U.S. Food and Drug Administration (FDA) | date=5 September 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm | access-date=11 February 2020 | archive-date=18 December 2019 | archive-url=https://web.archive.org/web/20191218044930/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm | url-status=dead }}

In November 2019, adalimumab-afzb (Abrilada) was approved in the United States.{{cite web | title=Abrilada- adalimumab-afzb kit; Abrilada- adalimumab-afzb injection, solution | website=DailyMed | date=26 January 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f | access-date=11 March 2024 | archive-date=30 April 2024 | archive-url=https://web.archive.org/web/20240430044519/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f | url-status=live }}{{cite web | title=Abrilada- adalimumab-afzb kit; Abrilada- adalimumab-afzb solution | website=DailyMed | date=26 January 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81a33cfa-262f-4432-a05d-7dd260928437 | access-date=11 March 2024 | archive-date=30 April 2024 | archive-url=https://web.archive.org/web/20240430044538/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81a33cfa-262f-4432-a05d-7dd260928437 | url-status=live }}{{cite web | title=Abrilada: FDA-Approved Drugs | publisher=U.S. Food and Drug Administration (FDA) | date=15 November 2019 | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761118 | archive-url=https://web.archive.org/web/20191207063708/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761118 | archive-date=7 December 2019 | url-status=live | access-date=6 December 2019}}{{cite web | title=Drug Approval Package: Abrilada | publisher=U.S. Food and Drug Administration (FDA) | date=28 January 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm | access-date=11 February 2020 | archive-date=4 October 2020 | archive-url=https://web.archive.org/web/20201004035524/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm | url-status=live }} It is the 25th biosimilar approved by the FDA.{{cite web | title=Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, on FDA's continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product | publisher=U.S. Food and Drug Administration (FDA) | date=15 November 2019 | url=https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug | archive-url=https://web.archive.org/web/20191119020728/https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug | archive-date=19 November 2019 | url-status=live | access-date=18 November 2019}} {{PD-notice}}

In February 2020, the biosimilar Amsparity was approved for use in the European Union.{{cite web | title=Amsparity EPAR | website=European Medicines Agency (EMA) | date=9 December 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity | access-date=18 February 2020 | archive-date=18 February 2020 | archive-url=https://web.archive.org/web/20200218190500/https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity | url-status=live }}

In June 2020, the biosimilar Idacio was approved for use in Australia.{{cite web | title=AusPAR: Adalimumab | website=Therapeutic Goods Administration (TGA) | date=23 September 2020 | url=https://www.tga.gov.au/resources/auspar/auspar-adalimumab-4 | access-date=23 September 2020 | archive-date=27 October 2020 | archive-url=https://web.archive.org/web/20201027142544/https://www.tga.gov.au/auspar/auspar-adalimumab-4 | url-status=live }}

In July 2020, adalimumab-fkjp (Hulio) was approved for use in the United States.{{cite web | title=Hulio- adalimumab kit | website=DailyMed | date=9 August 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0518a75-8240-4172-aff7-1e03fd9523be | access-date=6 October 2023 | archive-date=6 October 2023 | archive-url=https://web.archive.org/web/20231006192824/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0518a75-8240-4172-aff7-1e03fd9523be | url-status=live }}{{cite web | title=Drug Approval Package: Hulio | publisher=U.S. Food and Drug Administration (FDA) | date=2 October 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm | access-date=27 December 2021 | archive-date=6 November 2021 | archive-url=https://web.archive.org/web/20211106210639/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm | url-status=live }}

In August 2020, the biosimilar Cadalimab was launched in India by Cadila Pharmaceuticals.{{cite press release | title=Cadila Pharmaceuticals launches Cadalimab (Adalimumab biosimilar) for India | website=Cadila Pharmaceuticals | date=28 August 2020 | url=https://www.cadilapharma.com/news-release/cadila-pharmaceuticals-cadalimab-adalimumab/ | access-date=11 February 2023 | archive-date=30 November 2022 | archive-url=https://web.archive.org/web/20221130141016/https://www.cadilapharma.com/news-release/cadila-pharmaceuticals-cadalimab-adalimumab/ | url-status=live }}{{cite web|date=29 August 2020|title=Cadila Pharma launches Cadalimab (adalimumab biosimilar) for India|url=https://www.expresspharma.in/latest-updates/cadila-pharma-launches-cadalimab-adalimumab-biosimilar-for-india/|access-date=7 September 2020|website=Express Pharma|archive-date=10 June 2022|archive-url=https://web.archive.org/web/20220610051124/https://www.expresspharma.in/cadila-pharma-launches-cadalimab-adalimumab-biosimilar-for-india/|url-status=live}}

Idacio was approved for medical use in Canada in October 2020.{{cite web | title=Summary Basis of Decision (SBD) for Idacio | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00518&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530045545/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00518&lang=en | url-status=live }}

In November 2020, Amgevita, Hulio, and Hyrimoz were approved for medical use in Canada.{{cite web | title=Summary Basis of Decision (SBD) for Amgevita | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00538&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530035528/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00538&lang=en | url-status=live }}{{cite web | title=Summary Basis of Decision (SBD) for Hulio | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00541&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529230129/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00541&lang=en | url-status=live }}{{cite web | title=Summary Basis of Decision (SBD) for Hyrimoz | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00535&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530043012/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00535&lang=en | url-status=live }}

Yuflyma was approved for medical use in the European Union in February 2021.{{cite web | title=Yuflyma EPAR | website=European Medicines Agency (EMA) | date=9 December 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma | access-date=27 February 2021 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828065111/https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma | url-status=live }}

In January 2021, Abrilada was approved for medical use in Canada.{{cite web | title=Summary Basis of Decision (SBD) for Abrilada | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00552&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529224341/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00552&lang=en | url-status=live }}

The biosimilars Libmyris and Hukyndra were approved for medical use in the European Union in November 2021.{{cite web | title=Libmyris EPAR | website=European Medicines Agency (EMA) | date=14 September 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris | access-date=23 April 2022 | archive-date=24 April 2022 | archive-url=https://web.archive.org/web/20220424041731/https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris | url-status=live }}{{cite web | title=Hukyndra EPAR | website=European Medicines Agency (EMA) | date=14 September 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra | access-date=23 April 2022 | archive-date=24 April 2022 | archive-url=https://web.archive.org/web/20220424041728/https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra | url-status=live }}

In December 2021, adalimumab-aqvh (Yusimry) was approved for medical use in the United States.{{cite web | title=Yusimry- adalimumab-aqvh injection, solution | website=DailyMed | date=31 March 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd0e7af2-7704-49ce-bde9-f645294b6788 | access-date=6 October 2023 | archive-date=6 October 2023 | archive-url=https://web.archive.org/web/20231006192824/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd0e7af2-7704-49ce-bde9-f645294b6788 | url-status=live }}{{cite web | title=Biosimilar Drug Information | publisher=U.S. Food and Drug Administration (FDA) | date=27 December 2021 | url=https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | access-date=27 December 2021 | archive-date=28 August 2021 | archive-url=https://web.archive.org/web/20210828185647/https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | url-status=dead }}{{cite press release | title=Coherus Announces U.S. FDA Approval of Yusimry (adalimumab-aqvh) | website=Coherus BioSciences | via=GlobeNewswire | date=20 December 2021 | url=https://www.globenewswire.com/news-release/2021/12/20/2355175/33333/en/Coherus-Announces-U-S-FDA-Approval-of-YUSIMRY-adalimumab-aqvh.html | access-date=27 December 2021 | archive-date=28 December 2021 | archive-url=https://web.archive.org/web/20211228055928/https://www.globenewswire.com/news-release/2021/12/20/2355175/33333/en/Coherus-Announces-U-S-FDA-Approval-of-YUSIMRY-adalimumab-aqvh.html | url-status=live }}

In December 2021, Yuflyma was approved for medical use in Canada.{{cite web | title=Summary Basis of Decision (SBD) for Yuflyma | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00584&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529191332/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00584&lang=en | url-status=live }}

In January 2022, Simlandi was approved for medical use in Canada.{{cite web | title=Summary Basis of Decision (SBD) for Simlandi | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00585&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529191115/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00585&lang=en | url-status=live }}{{cite press release | title=JAMP and Alvotech Announce Canadian Approval of Simlandi, a High-Concentration Biosimilar to Humira, Providing Access to Previously Unavailable Versions in Canada | publisher=Alvotech | via=Business Wire | date=10 January 2022 | url=https://www.businesswire.com/news/home/20220110005496/en/JAMP-and-Alvotech-Announce-Canadian-Approval-of-SIMLANDI%E2%84%A2-a-High-Concentration-Biosimilar-to-Humira%C2%AE-Providing-Access-to-Previously-Unavailable-Versions-in-Canada | access-date=26 February 2024 | archive-date=26 February 2024 | archive-url=https://web.archive.org/web/20240226053858/https://www.businesswire.com/news/home/20220110005496/en/JAMP-and-Alvotech-Announce-Canadian-Approval-of-SIMLANDI%E2%84%A2-a-High-Concentration-Biosimilar-to-Humira%C2%AE-Providing-Access-to-Previously-Unavailable-Versions-in-Canada | url-status=live }}

Adalimumab-aacf (Idacio) was approved for medical use in the United States in December 2022.{{cite web | title=Idacio- adalimumab injection, solution | website=DailyMed | date=22 March 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=43de75ac-1a37-4609-9edd-68bda2448a47 | access-date=11 March 2024 | archive-date=11 March 2024 | archive-url=https://web.archive.org/web/20240311074814/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=43de75ac-1a37-4609-9edd-68bda2448a47 | url-status=live }}{{cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761255Orig1s000TOC.cfm |title=Drug Approval Package: Idacio |publisher=U.S. Food and Drug Administration (FDA) |access-date=9 February 2023 |date=9 February 2023 |archive-date=10 February 2023 |archive-url=https://web.archive.org/web/20230210001159/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761255Orig1s000TOC.cfm |url-status=dead }}

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.{{cite web |date=30 January 2023 |title=Sandoz's high concentration Hyrimoz formulation recommended for use in EU |url=https://www.pmlive.com/pharma_news/sandozs_high_concentration_hyrimoz_formulation_recommended_for_use_in_eu_1486045 |access-date=31 January 2023 |website=PMLive |archive-date=31 January 2023 |archive-url=https://web.archive.org/web/20230131102112/https://www.pmlive.com/pharma_news/sandozs_high_concentration_hyrimoz_formulation_recommended_for_use_in_eu_1486045 |url-status=live }}

In January 2023, Simlandi was approved for medical use in Saudi Arabia.{{cite web | title=Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia | website=Alvotech | date=24 January 2023 | url=https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-bioventure-announce-approval-avt02-adalimumab | access-date=26 February 2024 | archive-date=26 February 2024 | archive-url=https://web.archive.org/web/20240226053859/https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-bioventure-announce-approval-avt02-adalimumab | url-status=live }}

Adalimumab-aaty (Yuflyma) was approved for medical use in the United States in May 2023.{{cite press release | title=Celltrion USA Announces U.S. FDA Approval of Yuflyma (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira (adalimumab) Biosimilar | publisher=Celltrion | via=Business Wire | date=24 May 2023 | url=https://www.businesswire.com/news/home/20230524005407/en/Celltrion-USA-Announces-U.S.-FDA-Approval-of-Yuflyma%C2%AE-adalimumab-aaty-a-High-Concentration-and-Citrate-Free-Formulation-of-Humira%C2%AE-adalimumab-Biosimilar | access-date=28 May 2023 | archive-date=25 May 2023 | archive-url=https://web.archive.org/web/20230525103024/http://www.businesswire.com/news/home/20230524005407/en/Celltrion-USA-Announces-U.S.-FDA-Approval-of-Yuflyma%C2%AE-adalimumab-aaty-a-High-Concentration-and-Citrate-Free-Formulation-of-Humira%C2%AE-adalimumab-Biosimilar/ | url-status=live }}{{cite web | title=Drug Approval Package: Yuflyma injection | website=U.S. Food and Drug Administration (FDA) | date=11 August 2023 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm | access-date=11 March 2024 | archive-date=25 August 2023 | archive-url=https://web.archive.org/web/20230825223940/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm | url-status=live }}

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.{{cite web |title=So it begins: next Humira biosimilars launch in US |url=https://pharmaphorum.com/news/so-it-begins-next-humira-biosimilars-launch-us |access-date=4 July 2023 |website=pharmaphorum |date=4 July 2023 |archive-date=5 July 2023 |archive-url=https://web.archive.org/web/20230705041758/https://pharmaphorum.com/news/so-it-begins-next-humira-biosimilars-launch-us |url-status=live }}{{cite news | vauthors = Wingrove P |date=30 June 2023 |title=Analysis: New Humira rivals likely to hit US market with small discounts in July |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/new-humira-rivals-likely-hit-us-market-with-small-discounts-july-2023-06-30/ |access-date=4 July 2023 |archive-date=30 June 2023 |archive-url=https://web.archive.org/web/20230630101800/https://www.reuters.com/business/healthcare-pharmaceuticals/new-humira-rivals-likely-hit-us-market-with-small-discounts-july-2023-06-30/ |url-status=live }}{{cite news | vauthors = Wingrove P |date=1 July 2023 |title=Organon, Samsung Bioepis launch copycat for arthritis drug Humira at 85% discount |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/organon-samsung-bioepis-launch-copycat-arthritis-drug-humira-85-discount-2023-07-01/ |access-date=4 July 2023 |archive-date=1 July 2023 |archive-url=https://web.archive.org/web/20230701211213/https://www.reuters.com/business/healthcare-pharmaceuticals/organon-samsung-bioepis-launch-copycat-arthritis-drug-humira-85-discount-2023-07-01/ |url-status=live }}

In February 2024, adalimumab-ryvk (Simlandi) was approved for medical use in the United States.{{cite press release | title=Alvotech and Teva Announce U.S. Approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira | publisher=Alvotech | via=GlobeNewswire | date=24 February 2024 | url=https://www.globenewswire.com/us/news-release/2024/02/24/2834699/0/en/Alvotech-and-Teva-Announce-U-S-Approval-of-SIMLANDI-adalimumab-ryvk-injection-the-first-interchangeable-high-concentration-citrate-free-biosimilar-to-Humira.html | access-date=26 February 2024 | archive-date=26 February 2024 | archive-url=https://web.archive.org/web/20240226053858/https://www.globenewswire.com/us/news-release/2024/02/24/2834699/0/en/Alvotech-and-Teva-Announce-U-S-Approval-of-SIMLANDI-adalimumab-ryvk-injection-the-first-interchangeable-high-concentration-citrate-free-biosimilar-to-Humira.html | url-status=live }}{{cite web | title=Simlandi- adalimumab-ryvk kit | website=DailyMed | date=23 February 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=12f609c9-2088-bb05-e063-6394a90a9ecc | access-date=2 April 2024 | archive-date=2 April 2024 | archive-url=https://web.archive.org/web/20240402060833/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=12f609c9-2088-bb05-e063-6394a90a9ecc | url-status=live }}

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. In November 2004, the trial began, and in December 2004, Justice Hugh Laddie ruled for CAT.

A short version of the full statement of the proceedings was released.{{cite news |title=Cambridge Antibody Technology prevails in High Court proceedings regarding Humira |url=https://www.cambridgenetwork.co.uk/news/486871 |access-date=5 January 2021 |work=www.cambridgenetwork.co.uk |publisher=Cambridge Network |date=20 December 2004 |archive-date=9 January 2021 |archive-url=https://web.archive.org/web/20210109043931/https://www.cambridgenetwork.co.uk/news/486871 |url-status=live }} 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. It should have calculated on the basis of the full royalty of just over 5% and should have paid and continued to pay CAT accordingly." 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. For this reason CAT wins the action."{{cite news | url=http://news.bbc.co.uk/1/hi/business/4112235.stm | work=BBC News Online | title=Biotech firm wins royalty fight | date=20 December 2004 | access-date=23 April 2010 | archive-date=27 August 2021 | archive-url=https://web.archive.org/web/20210827205029/https://secure-uk.imrworldwide.com/cgi-bin/m?rnd=1630097429343&ci=bbc&cg=0&sr=1600x1000&ts=v51.js&cd=24&lg=en-US&je=n&ck=y&tz=0&ct=&hp=&tl=BBC%20NEWS%20%7C%20Business%20%7C%20Biotech%20firm%20wins%20royalty%20fight&si=http%3A%2F%2Fnews.bbc.co.uk%2F2%2Fhi%2Fbusiness%2F4112235.stm&rp= | url-status=live }}

Abbott was required to pay CAT {{US$|255{{nbsp}}million}}, some of which was to be passed to its partners in development.{{cite news | url=https://www.telegraph.co.uk/finance/2924694/Drug-maker-CAT-surges-after-royalty-settlement.html | work=The Telegraph | location=London | title=Drug maker CAT surges after royalty settlement | vauthors = Murray-West R | date=27 October 2005 | access-date=23 April 2010 | archive-date=20 September 2018 | archive-url=https://web.archive.org/web/20180920114809/https://www.telegraph.co.uk/finance/2924694/Drug-maker-CAT-surges-after-royalty-settlement.html | url-status=live }} Of this sum, the Medical Research Council received {{US$|191{{nbsp}}million}}, and in addition, Abbott was asked to pay the MRC a further {{US$|7.5{{nbsp}}million}} over five years from 2006, providing that Humira remains on the market. The MRC also is to receive a further £5.1{{nbsp}}million (sterling) in respect of past royalties.{{cite press release|url= http://www.mrctechnology.org/resources/PR/MRC_Humira_PRESS_RELEASE.pdf |title=Multi-Million Dollar Deal To Benefit Medical Research |publisher=Medical Research Council |access-date=20 July 2009 |url-status=dead |archive-url= https://web.archive.org/web/20070627194553/http://www.mrctechnology.org/resources/PR/MRC_Humira_PRESS_RELEASE.pdf |archive-date=27 June 2007 }}

In May 2009, Johnson & Johnson's Centocor unit, the maker of infliximab, won a ruling for $1.67{{nbsp}}billion from Abbott Laboratories for patent infringement on the process for making Humira.[https://scholar.google.com/scholar_case?case=3988866797724338370&q=Centocor+Ortho+Biotech,+Inc.+v.+Abbott+Laboratories,+669+F.+Supp.+2d+756+(E.D.+Tex.+2009)&hl=en&as_sdt=20006 Centocor Ortho Biotech, Inc. v. Abbott Lab'ys, 669 F. Supp. 2d 756 (E.D. Tex. 2009)] {{Webarchive|url=https://web.archive.org/web/20220322205203/https://scholar.google.com/scholar_case?case=3988866797724338370&q=Centocor+Ortho+Biotech,+Inc.+v.+Abbott+Laboratories,+669+F.+Supp.+2d+756+(E.D.+Tex.+2009)&hl=en&as_sdt=20006 |date=22 March 2022 }}, rev'd, 636 F.3d 1341 (Fed. Cir. 2011).{{cite news | vauthors = Pierson R, Spicer J | title=Jury returns $1.67 billion drug verdict against Abbott | website=Reuters | date=30 June 2009 | url=https://www.reuters.com/article/us-johnsonjohnson-abbott-humira-idUSTRE55T15Q20090630 | access-date=9 September 2019 | archive-date=2 March 2021 | archive-url=https://web.archive.org/web/20210302171252/https://www.reuters.com/article/us-johnsonjohnson-abbott-humira-idUSTRE55T15Q20090630 | url-status=live }} However, in 2011, the judgment was overturned by the United States Court of Appeals for the Federal Circuit.{{cite web | title=Centocor Ortho Biotech v. Abbott Laboratories, 636 F. 3d 1341 | publisher=United States Court of Appeals for the Federal Circuit | via=Google Scholar | url=https://scholar.google.com/scholar_case?case=2674528643033496852 | date=23 February 2011 | access-date=9 September 2019 | archive-date=27 August 2021 | archive-url=https://web.archive.org/web/20210827205025/https://scholar.google.com/scholar_case?case=2674528643033496852 | url-status=live }}{{cite news | vauthors = Decker S | url = http://www.businessweek.com/news/2011-02-23/abbott-wins-reversal-of-j-j-s-1-67-billion-patent-victory.html | title = Abbott Wins Reversal of J&J's $1.67 Billion Patent Victory | work = Bloomberg Businessweek |date = 23 February 2011 | url-status = dead | archive-url = https://web.archive.org/web/20110506001424/http://www.businessweek.com/news/2011-02-23/abbott-wins-reversal-of-j-j-s-1-67-billion-patent-victory.html | archive-date = 6 May 2011 | df = dmy-all }} 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.{{cite news | vauthors = Silbersher Z | title=Why was the Humira "patent thicket" antitrust case against AbbVie dismissed? | website=Markman Advisors | date=10 June 2020 | url=https://www.markmanadvisors.com/blog/2020/6/10/why-was-the-humira-patent-thicket-antitrust-case-against-abbvie-dismissed | access-date=6 October 2020 | archive-date=20 September 2020 | archive-url=https://web.archive.org/web/20200920234011/https://www.markmanadvisors.com/blog/2020/6/10/why-was-the-humira-patent-thicket-antitrust-case-against-abbvie-dismissed | url-status=live }} The dismissal was affirmed by the Seventh Circuit Court of Appeals on 1 August 2022.[http://media.ca7.uscourts.gov/cgi-bin/rssExec.pl?Submit=Display&Path=Y2022/D08-01/C:20-2402:J:Easterbrook:aut:T:fnOp:N:2911279:S:0 Mayor and City of Baltimore, et al. v. AbbVIE Inc., et al.] {{Webarchive|url=https://web.archive.org/web/20220803113955/http://media.ca7.uscourts.gov/cgi-bin/rssExec.pl?Submit=Display&Path=Y2022%2FD08-01%2FC%3A20-2402%3AJ%3AEasterbrook%3Aaut%3AT%3AfnOp%3AN%3A2911279%3AS%3A0 |date=3 August 2022 }}, 7th Circuit Court of Appeals (decided 1 August 2022).

AbbVie has extensively used the US patent system to delay competitors from entering the market, a process commonly known as "evergreening".{{cite web |work=The National Law Review |access-date=28 January 2023 | vauthors = Hansen K, Kolinsky MA |url=https://www.natlawreview.com/article/humira-how-far-can-drug-makers-go-to-protect-their-branded-market |title=Humira: How far can drug makers go to protect their branded market? |date=17 February 2020 |archive-date=21 January 2022 |archive-url=https://web.archive.org/web/20220121205637/https://www.natlawreview.com/article/humira-how-far-can-drug-makers-go-to-protect-their-branded-market |url-status=live }} It filed 311 patents for Humira, of which 165 were granted. AbbVie sued Amgen, the manufacturer of Amjevita, in 2016 for violating 10 of its patents. Amgen agreed to delay sales until 2023, which allowed AbbVie to drive up prices of Humira. Between 2016 and 2023, the price of Humira went up by 60%, during which time AbbVie made $114{{nbsp}}billion in revenue from Humira.{{cite news |title=How a Drug Company Made $114 Billion by Gaming the US Patent System | vauthors = Rebecca R |newspaper=The New York Times |date=28 January 2023 |access-date=28 January 2023 |url=https://www.nytimes.com/2023/01/28/business/humira-abbvie-monopoly.html |archive-date=28 January 2023 |archive-url=https://web.archive.org/web/20230128101555/https://www.nytimes.com/2023/01/28/business/humira-abbvie-monopoly.html |url-status=live }}

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