Chemistry:Adalimumab

From HandWiki
Short description: Monoclonal antibody pharmaceutical drug
Adalimumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetTNF alpha
Clinical data
Trade namesHumira
Other namesD2E7
AHFS/Drugs.comMonograph
MedlinePlusa603010
License data
Pregnancy
category
Routes of
administration		Subcutaneous
Drug classTNF inhibitor
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability64% (subcutaneous), 0% (by mouth)
Elimination half-life10–20 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6428H9912N1694O1987S46
Molar mass144190.64 g·mol−1
 ☒N☑Y (what is this?)  (verify)

Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.[41][42][43] It is administered by subcutaneous injection (injection under the skin).[41] It works by inactivating tumor necrosis factor-alpha (TNFα).[41]

Common side effects include upper respiratory tract infections, pain at the site of injection, rash, and headache.[41] Other side effects may include serious infections, cancer, anaphylaxis, reactivation of hepatitis B, new onset or exacerbation of demyelinating diseases (such as multiple sclerosis), heart failure, liver failure, and aplastic anemia.[41] Use during pregnancy is not recommended, but some sources show use during breastfeeding may be safe.[1][42]

Adalimumab was approved for medical use in the United States in 2002.[41][44] It is on the World Health Organization's List of Essential Medicines.[45][46] It is available as a biosimilar medication.[47] In 2020, it was the 205th most commonly prescribed medication in the United States, with more than 2.3 million prescriptions.[48][49]

Medical uses

In the U.S. 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.[11][50][19] In the EU it is also indicated for chronic aggressive progressive pulmonary and bone sarcoidosis.[19]

Rheumatoid arthritis

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.[51] 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.[52] It has a similar effectiveness as methotrexate and, in combination, nearly doubles the response rate of methotrexate alone.[53]

Juvenile idiopathic arthritis

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.[54][55][56]

Ankylosing spondylitis

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

Crohn's disease

Adalimumab has been shown to reduce the signs and symptoms of moderate to severe Crohn's disease.[47][58][59] It has been approved for that use in the UK since 2009.[60]

Ulcerative colitis

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.[61][62]

Plaque psoriasis

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).[63] Adalimumab has been shown to be effective therapy when used either continuously or intermittently in patients with moderate to severe psoriasis.[64]

Hidradenitis suppurativa

Adalimumab was approved for hidradenitis suppurativa in 2015.[43][65][66]

Non-infectious uveitis

Adalimumab is indicated for the treatment of non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).[11][19]

Adverse effects

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.[67] 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.[68]

There are rare reports of serious liver injury; rare reports of demyelinating central nervous system disorders; and rare reports of cardiac failure—the US Food and Drug Administration (FDA) issued a black box warning to doctors, which appears in the product labeling of adalimumab and other TNF-inhibiting drugs, instructing them to screen and monitor potential patients more carefully.[69] Anaphylaxis or other serious allergic reactions may also occur.[69]

Injection site reactions such as redness and pain are very common, and may occur in up to 80% of cases.[70]

History

Adalimumab was the first fully human monoclonal antibody approved by the US Food and Drug Administration (FDA).[71] It is derived from phage display.[71][72]

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.[71][73]

Initially named D2E7,[74] 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.[75] As a result, AbbVie took over development and marketing of Humira.[76][77] 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.[71] It is constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept is a TNF receptor-IgG fusion protein.

The drug candidate was discovered initially using CAT's phage display technology and named D2E7.[74] 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.[78] 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.[79]

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]

Adalimumab, sold under the brand name Humira, was approved for use in the United States in 2002.[44][80]

Adalimumab, sold under the brand names Humira and Trudexa, was approved for use in the European Union in September 2003.[19][81]

Research

  • 1999: Preliminary results of early clinical trials with the fully human anti-TNFα monoclonal antibody D2E7[74]
  • 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.[82]
  • 2002: Broke ground on a new biologics manufacturing facility.[83]
  • 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.[84]
  • 2002, 31 December: Humira approved by the U.S. Food and Drug Administration (FDA) for treatment of rheumatoid arthritis.[83]
  • 2003: Launched Humira for rheumatoid arthritis and continued clinical studies for additional indications.[83]
  • 2005: Launched Humira for psoriatic arthritis. Exceeded US$1 billion in annual sales for the first time.[83]
  • 2005: Eisai submits new drug application for adalimumab (D2E7) in Japan.[85]
  • 2006: Submitted Humira for the Crohn's disease indication and launched it for AS. Exceeded US$2 billion in annual sales.[83]
  • 2007: Launched Humira for Crohn's disease in the United States,[83] submitted Humira for global regulatory approval for psoriasis — the fifth Humira disease indication, achieved more than US$3 billion in worldwide Humira sales.[86]
  • 2007: Abbott opens new biotechnology manufacturing facility in Puerto Rico[87]
  • 2008: Launched Humira for plaque psoriasis[88]
  • 2009: Five-Year data demonstrate initial use of humira plus methotrexate may prevent further joint damage in early rheumatoid arthritis patients [89][90]
  • 2012: Humira could be associated with a significant decrease in vascular inflammation, a major risk factor of cardiovascular disease[91]
  • 2013: Bacause of the split of Abbott, Humira rights are now owned by AbbVie.[75][76]
  • 2014: Humira recognized by IMS Health as the "world's best selling drug".[92]
  • 2014: In December 2014, Indian drugmaker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its U.S. price. The generic was launched under the brand name Exemptia.[93]
  • 2015: Launched Humira for moderate to severe hidradenitis suppurativa, an orphan indication. No other treatment has been[when?] rigorously tested and found to be safe and effective in treating this condition.[43]

Society and culture

Economics

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.[94] 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.[95]

The best-selling drugs list published by Genetic Engineering & Biotechnology News, shows that Humira occupied the Template:No. position for 2015 (US$14.012 billion) and 2016 (US$16.078 billion)[96] From 2012 until the U.S. patent expired in 2016, Humira led the list of top-selling pharmaceutical products, and in 2016, it had US$16 billion of global sales.[96] AbbVie reported that Humira achieved US$18.427 billion of sales in 2017.[97] Humira had the largest worldwide drug sales in 2019 and 2020 of US$19.7bn and US$20.4bn respectively.[98]

Biosimilars

From 2014, biosimilars were manufactured by several companies and sold at a lower price than before patent expiry.[93]

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.[93] In 2016, Indian drugmaker Torrent Pharmaceuticals launched its biosimilar for adalimumab, called Adfrar. It is the second generic biosimilar of adalimumab.[99]

In September 2016, the FDA approved Amgen's biosimilar adalimumab-atto, sold under the brand name Amjevita.[21][100][101][102][103][104]

In August 2017, the FDA approved German pharmaceutical company Boehringer Ingelheim's biosimilar, Cyltezo.[20][105][106][107][104][108]

In 2017, the biosimilars Amgevita,[23] Solymbic,[38] Imraldi,[34] and Cyltezo[26] were approved for use in the European Union.

In 2018, the biosimilars Halimatoz,[28] Hefiya,[29] Hyrimoz,[32] and Hulio[31] were approved for use in the European Union.

Adalimumab biosimilars became available in the European Union in 2018,[109] allowing the National Health Service to make record-breaking cost-savings,[110] as this is the single most expensive drug used in NHS hospitals, costing more than £400 million a year for about 46,000 patients.[111]

In October 2018, adalimumab-adaz (Hyrimoz) was approved for use in the United States.[12][112]

In April 2019, Idacio[33] and Kromeya[35] 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.[16][113][114][104] However, it will not be available until at least June 2023, after the availability of Amgen's offering as a result of a negotiated intellectual property settlement with AbbVie.[115]

In November 2019, adalimumab-afzb (Abrilada) was approved in the United States.[14][116][117][104] It is the 25th biosimilar approved by the FDA.[118]

In February 2020, the biosimilar Amsparity was approved for use in the European Union.[24]

In June 2020, the biosimilar Idacio was approved for use in Australia.[7]

In July 2020, adalimumab-fkjp (Hulio) was approved for use in the United States.[17][119][104]

In August 2020, the biosimilar Cadalimab was launched in India by Cadila Pharmaceuticals.[25][120]

Idacio was approved for medical use in Canada in October 2020.[121]

In November 2020, Amgevita, Hulio, and Hyrimoz were approved for medical use in Canada.[122][123][124]

On 10 December 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yuflyma, intended for the treatment of certain inflammatory and autoimmune disorders.[125] The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. It was approved for medical use in the European Union in February 2021.[40]

In January 2021, Abrilada was approved for medical use in Canada.[22]

On 16 September 2021, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal products Libmyris and Hukyndra, intended for the treatment of certain inflammatory and autoimmune disorders.[126][127] The applicant for these medicinal products is Stada Arzneimittel.[126][127] The biosimilars Libmyris and Hukyndra were approved for medical use in the European Union in November 2021.[36][30]

In December 2021, adalimumab-aqvh (Yusimry) was approved for medical use in the United States.[15][128][104]

In December 2021, Yuflyma was approved for medical use in Canada.[129]

In January 2022, Simlandi was approved for medical use in Canada.[37]

Adalimumab-aacf (Idacio) was approved for medical use in the United States in December 2022.[13]

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.[130]

In February 2023, Amgen's biosimilar adalimumab-atto, sold under the brand name Amjevita was launched in the US.[131][132]

Adalimumab-aaty (Yuflyma) was approved for medical use in the United States in May 2023.[133]

Starting in July 2023, when Humira's regulatory exclusivity lapsed, a number of biosimilars such as Hadlima, Hyrimoz, Cyltezo, Celltrion were launched in the US.[134][135][136]

Royalty litigation

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.[137] 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."[138]

Abbott was required to pay CAT US$255 million, some of which was to be passed to its partners in development.[139] Of this sum, the Medical Research Council received US$191 million, and in addition, Abbott was asked to pay the MRC a further US$7.5 million over five years from 2006, providing that Humira remains on the market. The MRC also is to receive a further £5.1 million (sterling) in respect of past royalties.[140]

Patent litigation

On 29 May 2009, Johnson & Johnson's Centocor unit, the maker of infliximab, won a ruling for $1.67 billion from Abbott Laboratories for patent infringement on the process for making Humira.[141][142] However, in 2011, the judgment was overturned by the United States Court of Appeals for the Federal Circuit.[143][144] 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.[145] The dismissal was affirmed by the Seventh Circuit Court of Appeals on 1 August 2022.[146]

AbbVie has extensively used the US patent system to delay competitors from entering the market, a process commonly known as "evergreening".[147] 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 billion in revenue from Humira.[148]

References

  1. ↑ 1.0 1.1 "Adalimumab Pregnancy and Breastfeeding Warnings". https://www.drugs.com/pregnancy/adalimumab.html. 
  2. ↑ 2.0 2.1 "Yuflyma APMDS". 8 April 2022. https://www.tga.gov.au/resources/auspmd/yuflyma. 
  3. ↑ 3.0 3.1 3.2 3.3 "Ciptunec/Ardalicip APMDS". 27 September 2022. https://www.tga.gov.au/resources/auspmd/ciptunecardalicip. 
  4. ↑ AusPAR: Adalimumab (Report). September 2020. https://www.tga.gov.au/resources/auspar/auspar-adalimumab-1. Retrieved 6 October 2023. 
  5. ↑ AusPAR: Adalimumab (Report). September 2020. https://www.tga.gov.au/resources/auspar/auspar-adalimumab-2. Retrieved 6 October 2023. 
  6. ↑ AusPAR: Adalimumab (Report). September 2020. https://www.tga.gov.au/resources/auspar/auspar-adalimumab-3. Retrieved 6 October 2023. 
  7. ↑ 7.0 7.1 https://www.tga.gov.au/resources/auspar/auspar-adalimumab-4 >"AusPAR: Adalimumab". 23 September 2020. https://www.tga.gov.au/resources/auspar/auspar-adalimumab-4. 
  8. ↑ AusPAR: Adalimumab (Report). September 2020. https://www.tga.gov.au/resources/auspar/auspar-adalimumab-5. Retrieved 6 October 2023. 
  9. ↑ AusPAR: Adalimumab (Report). September 2020. https://www.tga.gov.au/resources/auspar/auspar-adalimumab-6. Retrieved 6 October 2023. 
  10. ↑ "Humira 40 mg solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". 27 November 2019. https://www.medicines.org.uk/emc/product/2150/smpc. 
  11. ↑ 11.0 11.1 11.2 "Humira- adalimumab kit Humira- adalimumab injection, solution". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d#section-1. 
  12. ↑ 12.0 12.1 12.2 "Hyrimoz: FDA-Approved Drugs". 30 October 2018. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761071.  This article incorporates text from this source, which is in the public domain.
  13. ↑ 13.0 13.1 13.2 "Drug Approval Package: Idacio". U.S. Food and Drug Administration (FDA). 9 February 2023. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761255Orig1s000TOC.cfm. 
  14. ↑ 14.0 14.1 14.2 "Abrilada (adalimumab-afzb) injection, for subcutaneous use". https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761118s000lbl.pdf. 
  15. ↑ 15.0 15.1 15.2 15.3 "Yusimry- adalimumab-aqvh injection, solution". 31 March 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd0e7af2-7704-49ce-bde9-f645294b6788. 
  16. ↑ 16.0 16.1 16.2 16.3 "Hadlima- adalimumab-bwwd solution". 11 July 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4774a951-3ce8-43b6-80b1-e6b23752aae6. 
  17. ↑ 17.0 17.1 17.2 "Hulio- adalimumab kit". 9 August 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0518a75-8240-4172-aff7-1e03fd9523be. 
  18. ↑ 18.0 18.1 18.2 "Yuflyma- adalimumab injection". 27 May 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=526d626f-8c9f-496c-b838-00a73bb36383. 
  19. ↑ 19.0 19.1 19.2 19.3 19.4 "Humira EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/humira.  Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  20. ↑ 20.0 20.1 "CYLTEZO- adalimumab-adbm kit". 12 July 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=115ea79b-7209-7f19-b35d-36ec0828fbf5. 
  21. ↑ 21.0 21.1 "Amjevita- adalimumab-atto injection". 11 April 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9c44bd5b-4464-40a4-8933-8680950f00f2. 
  22. ↑ 22.0 22.1 "Summary Basis of Decision (SBD) for Abrilada". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00552&lang=en. 
  23. ↑ 23.0 23.1 "Amgevita EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita. 
  24. ↑ 24.0 24.1 "Amsparity EPAR". 9 December 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/amsparity. 
  25. ↑ 25.0 25.1 "Cadila Pharmaceuticals launches Cadalimab (Adalimumab biosimilar) for India". Cadila Pharmaceuticals (Press release). 28 August 2020. Archived from the original on 30 November 2022. Retrieved 11 February 2023.
  26. ↑ 26.0 26.1 "Cyltezo EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/cyltezo. 
  27. ↑ "First biosimilar Humira launches in India". 17 December 2014. https://www.pmlive.com/pharma_news/first_biosimilar_humira_launches_in_india_625055. 
  28. ↑ 28.0 28.1 "Halimatoz EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/halimatoz. 
  29. ↑ 29.0 29.1 "Hefiya EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hefiya. 
  30. ↑ 30.0 30.1 "Hukyndra EPAR". 14 September 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/hukyndra. 
  31. ↑ 31.0 31.1 "Hulio EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hulio. 
  32. ↑ 32.0 32.1 "Hyrimoz EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz. 
  33. ↑ 33.0 33.1 "Idacio EPAR". 29 January 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/idacio. 
  34. ↑ 34.0 34.1 "Imraldi EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/imraldi. 
  35. ↑ 35.0 35.1 "Kromeya EPAR". 29 January 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/kromeya. 
  36. ↑ 36.0 36.1 "Libmyris EPAR". 14 September 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/libmyris. 
  37. ↑ 37.0 37.1 "Summary Basis of Decision (SBD) for Simlandi". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00585&lang=en. 
  38. ↑ 38.0 38.1 "Solymbic EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/solymbic. 
  39. ↑ "Trudexa EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa. 
  40. ↑ 40.0 40.1 "Yuflyma EPAR". 9 December 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/yuflyma. 
  41. ↑ 41.0 41.1 41.2 41.3 41.4 41.5 "Adalimumab Monograph for Professionals". American Society of Health-System Pharmacists. 14 May 2018. https://www.drugs.com/monograph/adalimumab.html. 
  42. ↑ 42.0 42.1 British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 1074. ISBN 9780857113382. 
  43. ↑ 43.0 43.1 43.2 "FDA Clears Adalimumab (Humira) for Hidradenitis Suppurativa". Medscape. 11 September 2015. https://www.medscape.com/viewarticle/850897. 
  44. ↑ 44.0 44.1 "Drug Approval Package: Humira (adalimumab)". 7 April 2017. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125057_toc.cfm. 
  45. ↑ World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. 2019. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO. 
  46. ↑ World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. 2021. WHO/MHP/HPS/EML/2021.02. 
  47. ↑ 47.0 47.1 "Anti-TNF biosimilars in Crohn's Disease: a patient-centric interdisciplinary approach". Expert Review of Gastroenterology & Hepatology 13 (8): 731–738. August 2019. doi:10.1080/17474124.2019.1645595. PMID 31322440. 
  48. ↑ "The Top 300 of 2020". https://clincalc.com/DrugStats/Top300Drugs.aspx. 
  49. ↑ "Adalimumab - Drug Usage Statistics". https://clincalc.com/DrugStats/Drugs/Adalimumab. 
  50. ↑ "Imraldi- adalimumab injection, solution". 23 January 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=acdfaa71-27ed-4717-8e7d-f1a5fe0d1fa6. 
  51. ↑ "Adalimumab for treating rheumatoid arthritis". The Cochrane Database of Systematic Reviews (3): CD005113. July 2005. doi:10.1002/14651858.CD005113.pub2. PMID 16034967. 
  52. ↑ "Product Approval Information - Licensing Action". 31 December 2002. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/adalabb123102L.htm.  This article incorporates text from this source, which is in the public domain.
  53. ↑ "Adalimumab (Humira) for the Treatment of Rheumatoid Arthritis". American Family Physician 78 (12): 1406–1408. 15 December 2008. ISSN 0002-838X. http://www.aafp.org/afp/2008/1215/p1406.html. Retrieved 9 September 2019. 
  54. ↑ "Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results". Arthritis Care & Research 72 (10): 1420–1430. October 2020. doi:10.1002/acr.24044. PMID 31421019. 
  55. ↑ "Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease". The Journal of Pediatrics 201: 166–175.e3. October 2018. doi:10.1016/j.jpeds.2018.05.042. PMID 30054164. 
  56. ↑ "Safety of weekly adalimumab in the treatment of juvenile idiopathic arthritis and pediatric chronic uveitis". Clinical Rheumatology 37 (2): 549–553. February 2018. doi:10.1007/s10067-017-3890-4. PMID 29103180. 
  57. ↑ "TNF-alpha inhibitors for ankylosing spondylitis". The Cochrane Database of Systematic Reviews 4 (4): CD005468. April 2015. doi:10.1002/14651858.CD005468.pub2. PMID 25887212. https://figshare.com/articles/journal_contribution/TNF-alpha_inhibitors_for_ankylosing_spondylitis/22957691/1/files/40695302.pdf. Retrieved 14 December 2019. 
  58. ↑ "Inflammatory bowel disease". The New England Journal of Medicine 347 (6): 417–429. August 2002. doi:10.1056/NEJMra020831. PMID 12167685. https://gut.bmj.com/content/gutjnl/39/Suppl_1/A15.full.pdf. Retrieved 24 September 2019. 
  59. ↑ "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". Current Medical Research and Opinion 35 (10): 1837–1846. October 2019. doi:10.1080/03007995.2019.1634952. PMID 31233347. 
  60. ↑ "UK – Summary of NICE Approvals in September 2009". 17 September 2009. https://worldpharmaoutlook.blogspot.com/2009/09/uk-summary-of-nice-approvals-in.html. 
  61. ↑ "FDA approves Humira to treat ulcerative colitis" (Press release). U.S. Food and Drug Administration (FDA). 28 September 2012. Archived from the original on 30 September 2012. This article incorporates text from this source, which is in the public domain.
  62. ↑ "Abbott's Humira (adalimumab) Receives U.S. FDA Approval for the Treatment of Adult Patients with Moderate to Severe Ulcerative Colitis". Abbott (Press release). 28 September 2012. Archived from the original on 19 November 2019. Retrieved 18 November 2019.
  63. ↑ "Adalimumab: in plaque psoriasis". American Journal of Clinical Dermatology 10 (1): 43–50. 2009. doi:10.2165/0128071-200910010-00008. PMID 19170412. 
  64. ↑ "Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial". Journal of the American Academy of Dermatology 58 (1): 106–115. January 2008. doi:10.1016/j.jaad.2007.09.010. PMID 17936411. 
  65. ↑ "Evidence-based approach to the treatment of hidradenitis suppurativa/acne inversa, based on the European guidelines for hidradenitis suppurativa". Reviews in Endocrine & Metabolic Disorders 17 (3): 343–351. September 2016. doi:10.1007/s11154-016-9328-5. PMID 26831295. 
  66. ↑ "Targeted treatments for hidradenitis suppurativa: a review of the current literature and ongoing clinical trials". The Journal of Dermatological Treatment 29 (5): 441–449. August 2018. doi:10.1080/09546634.2017.1395806. PMID 29098911. 
  67. ↑ "Risk of serious infections and malignancies with anti-TNF antibody therapy in rheumatoid arthritis". JAMA 296 (18): 2203; author reply 2203-2203; author reply 2204. November 2006. doi:10.1001/jama.296.18.2203-a. PMID 17090763. 
  68. ↑ "Do tumor necrosis factor inhibitors increase cancer risk in patients with chronic immune-mediated inflammatory disorders?". Cytokine 101: 78–88. January 2018. doi:10.1016/j.cyto.2016.09.013. PMID 27688201. 
  69. ↑ 69.0 69.1 "Humira Medication Guide". October 2018. http://www.rxabbott.com/pdf/humira_medguide.pdf. 
  70. ↑ "New adalimumab formulation associated with less injection site pain and improved motivation for treatment". Modern Rheumatology 29 (6): 949–953. November 2019. doi:10.1080/14397595.2018.1520426. PMID 30183438. 
  71. ↑ 71.0 71.1 71.2 71.3 "Phage display-derived human antibodies in clinical development and therapy". mAbs 8 (7): 1177–1194. October 2016. doi:10.1080/19420862.2016.1212149. PMID 27416017. 
  72. ↑ "Therapeutic antibodies for human diseases at the dawn of the twenty-first century". Nature Reviews. Drug Discovery 2 (1): 52–62. January 2003. doi:10.1038/nrd984. PMID 12509759. 
  73. ↑ "The long and winding road to antibody therapeutics". mAbs 2 (5): 459–460. 2010. doi:10.4161/mabs.2.5.13088. PMID 20978369. 
  74. ↑ 74.0 74.1 74.2 "Preliminary results of early clinical trials with the fully human anti-TNFalpha monoclonal antibody D2E7". Annals of the Rheumatic Diseases 58 (Suppl 1): I70–I72. November 1999. doi:10.1136/ard.58.2008.i70. PMID 10577977. 
  75. ↑ 75.0 75.1 "Abbott Completes Separation Of Research-Based Pharmaceuticals Business" (Press release). Abbott Laboratories. Archived from the original on 8 August 2020. Retrieved 9 September 2019.
  76. ↑ 76.0 76.1 "Humira: the highs and lows of the world's most successful drug". 5 September 2018. https://www.pharmaceutical-technology.com/features/humira-abbvie-drug/. 
  77. ↑ "Why Abbvie May Have A Tough Time Defending Humira's Price Before Congress". 26 February 2019. https://www.forbes.com/sites/brucejapsen/2019/02/26/why-abbvie-may-have-a-tough-time-defending-humiras-price-before-congress/. 
  78. ↑ "Guiding the selection of human antibodies from phage display repertoires to a single epitope of an antigen". Bio/Technology 12 (9): 899–903. September 1994. doi:10.1038/nbt0994-899. PMID 7521646. 
  79. ↑ "BASF to focus more strongly on innovative chemistry, a highly efficient Verbund and a global presence" (Press release). Archived from the original on 12 February 2013. Retrieved 9 December 2012.
  80. ↑ "Humira: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125057. 
  81. ↑ "Trudexa EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/trudexa. 
  82. ↑ "Abbott Laboratories' Investigational Fully Human Anti-Tnf Therapy, D2E7 (Adalimumab), Shows Promise In Reducing The Signs And Symptoms Of Rheumatoid Arthritis" (Press release). 12 November 2001. Archived from the original on 4 December 2019. Retrieved 9 September 2019.
  83. ↑ 83.0 83.1 83.2 83.3 83.4 83.5 "Abbott 2006 Annual Report". Abbott. http://truecostofhealthcare.org/wp-content/uploads/2015/01/Abbott_Report_2006.87103312.pdf. 
  84. ↑ "Adalimumab (a fully human anti-tumour necrosis factor alpha monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials". Annals of the Rheumatic Diseases 61 (Suppl 2): ii70–ii73. November 2002. doi:10.1136/ard.61.suppl_2.ii70. PMID 12379628. 
  85. ↑ "Eisai Submits New Drug Application for Rheumatoid Arthritis Drug Adalimumab (D2E7) in Japan.". thefreelibrary.com. http://www.thefreelibrary.com/Eisai+Submits+New+Drug+Application+for+Rheumatoid+Arthritis+Drug...-a0140148456. 
  86. ↑ "Abbott 2007 Annual Report". Abbott. http://truecostofhealthcare.org/wp-content/uploads/2015/01/Abbott_Report_2007.87102217.pdf. 
  87. ↑ "Abbott Opens New Biotechnology Manufacturing Facility In Puerto Rico" (Press release). Abbott. 10 April 2007. Archived from the original on 30 May 2009. Retrieved 27 July 2009.
  88. ↑ "Abbott's Humira (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis" (Press release). Abbott Laboratories. 18 January 2008. Archived from the original on 7 August 2020. Retrieved 9 September 2019.
  89. ↑ "Five-Year Data Demonstrate Initial Use Of Abbott's Humira (Adalimumab) Plus Methotrexate May Prevent Further Joint Damage In Early Rheumatoid Arthritis Patients" (Press release). Abbott. Archived from the original on 22 March 2010. Retrieved 27 July 2009.
  90. ↑ "Long-term use of adalimumab in the treatment of rheumatic diseases". Open Access Rheumatology: Research and Reviews 1: 51–68. 2009. doi:10.2147/oarrr.s4297. PMID 27789981. 
  91. ↑ "Treating psoriasis to prevent heart attacks and strokes". https://www.sciencedaily.com/releases/2012/03/120316101632.htm. 
  92. ↑ "Humira Lifts AbbVie 2.8% in Q2". Discovery and Development. Associated Press. 25 July 2014. http://www.dddmag.com/news/2014/07/humira-lifts-abbvie-28-q2. 
  93. ↑ 93.0 93.1 93.2 "India's Cadila launches first cheaper copy of world's top-selling drug". Reuters. 9 December 2014. https://www.reuters.com/article/us-cadila-health-humira-india/indias-cadila-launches-first-cheaper-copy-of-worlds-top-selling-drug-idUSKBN0JN0X820141209. 
  94. ↑ "Adalimumab (Humira) and its biosimilars: medicine used for joint pain and inflammation". 18 February 2019. https://www.nhs.uk/medicines/adalimumab/. 
  95. ↑ "NHS set to save record £300 million on the NHS's highest drug spend". 26 November 2018. https://www.england.nhs.uk/2018/11/nhs-set-to-save-record-300-million-on-the-nhss-highest-drug-spend/. 
  96. ↑ 96.0 96.1 "The Top 15 Best-Selling Drugs of 2016". 6 March 2017. https://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868. 
  97. ↑ "AbbVie Reports Full-Year and Fourth-Quarter 2017 Financial Results". AbbVie (Press release). Archived from the original on 12 April 2018. Retrieved 8 March 2018.
  98. ↑ "Top companies and drugs by sales in 2020". Nature Reviews. Drug Discovery 20 (4): 253. April 2021. doi:10.1038/d41573-021-00050-6. PMID 33727694. 
  99. ↑ "Torrent launches world's second biosimilar of generic auto-immune drug". Business Standard. 11 January 2016. http://www.business-standard.com/article/companies/torrent-launches-world-s-second-biosimilar-of-generic-auto-immune-drug-116011100615_1.html. 
  100. ↑ "Amjevita- adalimumab-atto injection". 11 April 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7178e36-6787-45ab-8fee-be59bc6a4aa4. 
  101. ↑ "Drug Approval Package: Amjevita (adalimumab-atto)". 9 November 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024_toc.cfm. 
  102. ↑ "FDA approves Amjevita, a biosimilar to Humira". U.S. Food and Drug Administration (FDA) (Press release). 23 September 2016. Archived from the original on 19 November 2019. Retrieved 18 November 2019. This article incorporates text from this source, which is in the public domain.
  103. ↑ "Amjevita: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761024. 
  104. ↑ 104.0 104.1 104.2 104.3 104.4 104.5 "Biosimilar Drug Information". 27 December 2021. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. 
  105. ↑ "Drug Approval Package: Cyltezo (adalimumab-adbm)". 27 September 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761058Orig1s000TOC.cfm. 
  106. ↑ "FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira". 18 October 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira. 
  107. ↑ "Cyltezo: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761058. 
  108. ↑ "Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of multiple chronic inflammatory diseases" (Press release). Boehringer Ingelheim Pharmaceuticals. 29 August 2017. Archived from the original on 24 July 2019. Retrieved 19 March 2019.
  109. ↑ "First wave of Humira biosimilars enters EU market". 16 October 2018. https://www.biopharma-reporter.com/Article/2018/10/16/First-wave-of-Humira-biosimilars-enters-EU-market. 
  110. ↑ "NHS replaces highest-spend drug with £300m cheaper alternative". The Guardian. 26 November 2018. https://www.theguardian.com/society/2018/nov/26/nhs-replaces-highest-spend-drug-with-300m-cheaper-alternative. 
  111. ↑ "Most expensive NHS drug comes off patent". Pharmaceutical Journal. 18 October 2018. https://pharmaceutical-journal.com/article/news/most-expensive-nhs-drug-comes-off-patent. 
  112. ↑ "Drug Approval Package: Hyrimoz". 21 March 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761071Orig1s000TOC.cfm. 
  113. ↑ "Hadlima: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761059.  This article incorporates text from this source, which is in the public domain.
  114. ↑ "Drug Approval Package: Hadlima". 5 September 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm. 
  115. ↑ "FDA approves Humira biosimilar, but it won't hit the market for 4 years". Becker's Hospital Review. 24 July 2019. https://www.beckershospitalreview.com/pharmacy/fda-approves-humira-biosimilar-but-it-won-t-hit-the-market-for-4-years.html. 
  116. ↑ "Abrilada: FDA-Approved Drugs". 15 November 2019. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761118. 
  117. ↑ "Drug Approval Package: Abrilada". 28 January 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761118Orig1s000TOC.cfm. 
  118. ↑ "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". 15 November 2019. https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug.  This article incorporates text from this source, which is in the public domain.
  119. ↑ "Drug Approval Package: Hulio". 2 October 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm. 
  120. ↑ "Cadila Pharma launches Cadalimab (adalimumab biosimilar) for India". 29 August 2020. https://www.expresspharma.in/latest-updates/cadila-pharma-launches-cadalimab-adalimumab-biosimilar-for-india/. 
  121. ↑ "Summary Basis of Decision (SBD) for Idacio". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00518&lang=en. 
  122. ↑ "Summary Basis of Decision (SBD) for Amgevita". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00538&lang=en. 
  123. ↑ "Summary Basis of Decision (SBD) for Hulio". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00541&lang=en. 
  124. ↑ "Summary Basis of Decision (SBD) for Hyrimoz". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00535&lang=en. 
  125. ↑ "Yuflyma: Pending EC decision". 10 December 2020. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/yuflyma. 
  126. ↑ 126.0 126.1 "Libmyris: Pending EC decision". 16 September 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/libmyris. 
  127. ↑ 127.0 127.1 "Hukyndra: Pending EC decision". 16 September 2021. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/hukyndra. 
  128. ↑ "Coherus Announces U.S. FDA Approval of Yusimry (adalimumab-aqvh)". Coherus BioSciences (Press release). 20 December 2021. Archived from the original on 28 December 2021. Retrieved 27 December 2021 – via GlobeNewswire.
  129. ↑ "Summary Basis of Decision (SBD) for Yuflyma". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00584&lang=en. 
  130. ↑ "Sandoz's high concentration Hyrimoz formulation recommended for use in EU". 30 January 2023. https://www.pmlive.com/pharma_news/sandozs_high_concentration_hyrimoz_formulation_recommended_for_use_in_eu_1486045. 
  131. ↑ "AbbVie's Humira gets a U.S. rival, but costs could stay high" (in en). Reuters. 2023-02-01. https://www.reuters.com/business/healthcare-pharmaceuticals/abbvies-humira-gets-us-rival-costs-could-stay-high-2023-01-31/. 
  132. ↑ "Humira biosimilar settlement a 'win-win' for Amgen and AbbVie, lawyer". 3 October 2017. https://www.biopharma-reporter.com/Article/2017/10/03/Humira-biosimilar-settlement-a-win-win-for-Amgen-and-AbbVie-lawyer. 
  133. ↑ "Celltrion USA Announces U.S. FDA Approval of Yuflyma (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira (adalimumab) Biosimilar" (Press release). Celltrion. 24 May 2023. Archived from the original on 25 May 2023. Retrieved 28 May 2023 – via Business Wire.
  134. ↑ "So it begins: next Humira biosimilars launch in US" (in en). https://pharmaphorum.com/news/so-it-begins-next-humira-biosimilars-launch-us. 
  135. ↑ "Analysis: New Humira rivals likely to hit US market with small discounts in July" (in en). Reuters. 2023-06-30. https://www.reuters.com/business/healthcare-pharmaceuticals/new-humira-rivals-likely-hit-us-market-with-small-discounts-july-2023-06-30/. 
  136. ↑ "Organon, Samsung Bioepis launch copycat for arthritis drug Humira at 85% discount" (in en). Reuters. 2023-07-01. https://www.reuters.com/business/healthcare-pharmaceuticals/organon-samsung-bioepis-launch-copycat-arthritis-drug-humira-85-discount-2023-07-01/. 
  137. ↑ "Cambridge Antibody Technology prevails in High Court proceedings regarding Humira". www.cambridgenetwork.co.uk (Cambridge Network). 20 December 2004. https://www.cambridgenetwork.co.uk/news/486871. 
  138. ↑ "Biotech firm wins royalty fight". BBC News Online. 20 December 2004. http://news.bbc.co.uk/1/hi/business/4112235.stm. 
  139. ↑ "Drug maker CAT surges after royalty settlement". The Telegraph (London). 27 October 2005. https://www.telegraph.co.uk/finance/2924694/Drug-maker-CAT-surges-after-royalty-settlement.html. 
  140. ↑ "Multi-Million Dollar Deal To Benefit Medical Research" (PDF) (Press release). Medical Research Council. Archived from the original (PDF) on 27 June 2007. Retrieved 20 July 2009.
  141. ↑ Centocor Ortho Biotech, Inc. v. Abbott Lab'ys, 669 F. Supp. 2d 756 (E.D. Tex. 2009) , rev'd, 636 F.3d 1341 (Fed. Cir. 2011).
  142. ↑ "Jury returns $1.67 billion drug verdict against Abbott". 30 June 2009. https://www.reuters.com/article/us-johnsonjohnson-abbott-humira-idUSTRE55T15Q20090630. 
  143. ↑ "Centocor Ortho Biotech v. Abbott Laboratories, 636 F. 3d 1341". United States Court of Appeals for the Federal Circuit. 23 February 2011. https://scholar.google.com/scholar_case?case=2674528643033496852. 
  144. ↑ "Abbott Wins Reversal of J&J's $1.67 Billion Patent Victory". Bloomberg Businessweek. 23 February 2011. http://www.businessweek.com/news/2011-02-23/abbott-wins-reversal-of-j-j-s-1-67-billion-patent-victory.html. 
  145. ↑ "Why was the Humira "patent thicket" antitrust case against AbbVie dismissed?". 10 June 2020. https://www.markmanadvisors.com/blog/2020/6/10/why-was-the-humira-patent-thicket-antitrust-case-against-abbvie-dismissed. 
  146. ↑ Mayor and City of Baltimore, et al. v. AbbVIE Inc., et al. , 7th Circuit Court of Appeals (decided 1 August 2022).
  147. ↑ "Humira: How far can drug makers go to protect their branded market?". The National Law Review. 17 February 2020. https://www.natlawreview.com/article/humira-how-far-can-drug-makers-go-to-protect-their-branded-market. 
  148. ↑ "How a Drug Company Made $114 Billion by Gaming the US Patent System". The New York Times. 28 January 2023. https://www.nytimes.com/2023/01/28/business/humira-abbvie-monopoly.html. 



Retrieved from "https://handwiki.org/wiki/index.php?title=Chemistry:Adalimumab&oldid=3336827"