Ustekinumab

Last updated

Ustekinumab
Monoclonal antibody
Type Whole antibody
Source Human
Target IL-12 and IL-23
Clinical data
Trade names Stelara
Other namesCNTO 1275
Biosimilars ustekinumab-aekn, [1] ustekinumab-auub, [2] ustekinumab-srlf, [3] ustekinumab-ttwe, [4] Eksunbi, [5] [6] Fymskina, [7] [8] Imuldosa, [3] Jamteki, [9] Otulfi, [10] [11] [12] Pyzchiva, [4] [13] [14] Selarsdi, [1] Steqeyma, [15] [16] Uzpruvo, [17] Wezlana, [2] [18] Wezenla [19] [20]
AHFS/Drugs.com Monograph
MedlinePlus a611013
License data
Pregnancy
category
Routes of
administration 		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolism unknown [24]
Elimination half-life 15–32 days (average 3 weeks) [24]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C6482H10004N1712O2016S46
Molar mass 145648.06 g·mol−1
 X mark.svgNYes check.svgY  (what is this?)    (verify)

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, [27] targeting both IL-12 and IL-23. [28]

Contents

Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union, and ulcerative colitis in the US, and in the EU to people who have not responded to more traditional treatments. [25] [26] [29] [30] It was found not effective for multiple sclerosis. [31]

It is administered either by intravenous infusion or subcutaneous injection. [27] The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. [32]

Medical uses

Ustekinumab is used to treat psoriasis. [25] This includes psoriatic arthritis when it affects the skin. [27] [25] It is indicated for the treatment of adult and adolescent patients (12 years and older) with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, and adults with active psoriatic arthritis (PsA) alone or in combination with methotrexate. [25] [33] It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. [25]

In the European Union, ustekinumab is authorized for the treatment of moderate to severe plaque psoriasis in people above the age of six years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A); [26] active psoriatic arthritis in adults; [26] moderately to severely active Crohn's disease in adults; [26] and moderately to severely active ulcerative colitis in adults. [26]

Adverse effects

According to information provided by Centocor, maker of one medication based on ustekinumab, their version of ustekinumab is associated with several types of serious adverse effects. These include an increased risk of infection, such as by tuberculosis and an increased risk of certain types of cancer. As with some other immunosuppressant drugs like ciclosporin, the brain swelling of posterior reversible encephalopathy syndrome is a risk. The pharmaceutical company also reports serious allergic reaction as a possible side effect. More common side effects are upper respiratory infection, headache, tiredness, [34] and injection site reactions (such as pain or swelling). [35]

Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity. [36]

Pregnancy

It is unknown if the medication is safe during pregnancy or breastfeeding. [24]

Mechanism of action

Ustekinumab is designed to interfere with the triggering of the body's inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL-12 and IL-23 which help activate certain T-cells. It binds to the p-40 subunit of both IL-12 and IL-23 so that they subsequently cannot bind to their receptors. [37]

History

In December 2007, a biologic license application (BLA) with the US Food and Drug Administration (FDA) was filed by Centocor and Janssen-Cilag International (collaborator) submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA). In November 2008, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies. [26] [38]

Society and culture

Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis. [39] In September 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis. [40]

In December 2008, Health Canada approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. [41] [42]

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis. [43] [44]

The FDA approved ustekinumab in September 2016, for the treatment of Crohn's disease. [45]

Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults. [46]

In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis. [29] [26]

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis. [47] [48]

Biosimilars

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States. [2]

In November 2023, 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 Uzpruvo, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, [49] psoriatic arthritis and Crohn's disease in adults. [49] The applicant for this medicinal product is STADA Arzneimittel AG. [49] Uzpruvo is a biosimilar medicinal product. [49] Uzpruvo was authorized for medical use in the European Union in January 2024. [17] [50]

In November 2023, Jamteki was approved for medical use in Canada. [9] [51]

In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada. [52] [53]

In February 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults. [13] The applicant for this medicinal product is Samsung Bioepis NL B.V. [13] Pyzchiva is a biosimilar medicinal product. [13] Pyzchiva was authorized for medical use in the European Union in April 2024. [13] [14]

Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024. [1]

In April 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wezenla, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis and Crohn's disease in adults. [19] [54] The applicant for this medicinal product is Amgen Technology (Ireland) UC. [19] Wezenla was authorized for medical use in the European Union in June 2024. [19] [20]

Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024. [4]

In June 2024, the CHMP recommended granting a marketing authorization for Steqeyma, a biosimilar medicine for the treatment of adults with moderately-to severely-active Crohn's disease, plaque psoriasis, pediatric plaque psoriasis and psoriatic arthritis. [15] [55] The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. [15] Steqeyma was authorized for medical use in the European Union in August 2024. [15] [16]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eksunbi, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults. [5] The applicant for this medicinal product is Samsung Bioepis NL B.V. [5] Eksunbi is a biosimilar medicinal product. [5] Eksunbi is a biosimilar medicinal product. [5] Eksunbi was authorized for medical use in the European Union in September 2024. [5] [6]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Otulfi, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease. [10] The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH. [10] Otulfi is a biosimilar medicinal product. [10] Otulfi was authorized for medical use in the European Union in September 2024. [10] [11]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Fymskina, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn's disease. [7] The applicant for this medicinal product is Formycon AG. [7] Fymskina is a biosimilar medicinal product. [7] Fymskina was authorized for medical use in the European Union in September 2024. [7] [8]

In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada. [56]

In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada. [57] [58]

In September 2024, Otulfi was approved for medical use in the United States. [12] [59]

Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024. [3] [60]

Related Research Articles

<span class="mw-page-title-main">Infliximab</span> Biopharmaceutical drug for autoimmune disorders

Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.

Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Tumor necrosis factor alpha (TNFα) is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.

Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, hepatocellular carcinoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).

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. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).

<span class="mw-page-title-main">Certolizumab pegol</span> Pharmaceutical drug

Certolizumab pegol, sold under the brand name Cimzia, is a biopharmaceutical medication for the treatment of Crohn's disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is a fragment of a monoclonal antibody specific to tumor necrosis factor alpha (TNF-α) and is manufactured by UCB.

<span class="mw-page-title-main">Biological therapy for inflammatory bowel disease</span>

Biological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. Even for diseases of unknown cause, molecules that are involved in the disease process have been identified, and can be targeted for biological therapy. Many of these molecules, which are mainly cytokines, are directly involved in the immune system. Biological therapy has found a niche in the management of cancer, autoimmune diseases, and diseases of unknown cause that result in symptoms due to immune related mechanisms.

<span class="mw-page-title-main">Golimumab</span> Pharmaceutical drug

Golimumab, sold under the brand name Simponi, is a human monoclonal antibody which is used as an immunosuppressive medication. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor. Profound reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellaular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism. Golimumab is given via subcutaneous injection.

Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Tocilizumab was jointly developed by Osaka University and Chugai, and was licensed in 2003 by Hoffmann-La Roche.

<span class="mw-page-title-main">Tofacitinib</span> Medication

Tofacitinib, sold under the brand Xeljanz among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular course juvenile idiopathic arthritis, and ulcerative colitis. It is a janus kinase (JAK) inhibitor, discovered and developed by the National Institutes of Health and Pfizer.

Ixekizumab, sold under the brand name Taltz, is an injectable medication for the treatment of autoimmune diseases. Chemically, it is a form of a humanized monoclonal antibody. The substance acts by binding interleukin 17A and neutralizing it, reducing inflammation.

<span class="mw-page-title-main">Apremilast</span> Medication for psoriasis and psoriatic arthritis

Apremilast, sold under the brand name Otezla among others, is a medication for the treatment of certain types of psoriasis and psoriatic arthritis. The drug acts as a selective inhibitor of the enzyme phosphodiesterase 4 (PDE4) and inhibits spontaneous production of TNF-alpha from human rheumatoid synovial cells. It is taken by mouth.

Guselkumab, sold under the brand name Tremfya, is a monoclonal antibody against interleukin-23 used for the treatment of plaque psoriasis.

<span class="mw-page-title-main">Filgotinib</span> Chemical compound

Filgotinib, sold under the brand name Jyseleca, is a medication used for the treatment of rheumatoid arthritis (RA). It was developed by the Belgian-Dutch biotech company Galapagos NV.

Celltrion, Inc. is a biopharmaceutical company headquartered in Incheon, South Korea. Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion. Celltrion's founder, Seo Jung-jin, is the richest person in South Korea.

Risankizumab, sold under the brand name Skyrizi, is a humanized monoclonal antibody used for the treatment of plaque psoriasis, psoriatic arthritis, and Crohn's disease. It is designed to target interleukin 23A (IL-23A). It is given by subcutaneous injection.

<span class="mw-page-title-main">Upadacitinib</span> Biopharmaceutical drug

Upadacitinib, sold under the brand name Rinvoq, is a medication used for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, and axial spondyloarthritis. Upadacitinib is a Janus kinase (JAK) inhibitor that works by blocking the action of enzymes called Janus kinases. These enzymes are involved in setting up processes that lead to inflammation, and blocking their effect brings inflammation in the joints under control.

Mirikizumab, sold under the brand name Omvoh, is a monoclonal antibody used for the treatment of ulcerative colitis. It is designed to attach to interleukin-23 (IL-23) and block its activity.

Bimekizumab, sold under the brand name Bimzelx, is a humanized anti-IL17A, anti-IL-17F, and anti-IL17AF monoclonal antibody that is used to treat plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and ankylosing spondylitis.

Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP). It is an interleukin-36 receptor (IL-36R) antagonist. It is given via injection into a vein.

<span class="mw-page-title-main">Deucravacitinib</span> Chemical compound

Deucravacitinib, sold under the brand name Sotyktu, is a medication used for the treatment of moderate-to-severe plaque psoriasis. It is a tyrosine kinase 2 (TYK2) inhibitor and it is taken by mouth. It was developed by Bristol Myers Squibb.

References

  1. 1 2 3 "Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)" (Press release). Alvotech. 16 April 2024. Archived from the original on 17 April 2024. Retrieved 17 April 2024– via GlobeNewswire.
  2. 1 2 3 "FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases". U.S. Food and Drug Administration (Press release). 31 October 2023. Archived from the original on 13 November 2023. Retrieved 13 November 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. 1 2 3 "FDA Approves Imuldosa (ustekinumab-srlf), Accord BioPharma's Biosimilar to Stelara (ustekinumab), for the Treatment of Chronic Inflammatory Conditions" (Press release). Accord BioPharma. 14 October 2024. Retrieved 14 October 2024– via PR Newswire.
  4. 1 2 3 "Archived copy" (PDF). Archived (PDF) from the original on 2 July 2024. Retrieved 2 July 2024.{{cite web}}: CS1 maint: archived copy as title (link)
  5. 1 2 3 4 5 6 "Eksunbi EPAR". European Medicines Agency. 25 July 2024. Retrieved 29 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. 1 2 "Eksunbi Product information". Union Register of medicinal products. 13 September 2024. Retrieved 17 September 2024.
  7. 1 2 3 4 5 "Fymskina EPAR". European Medicines Agency. 25 July 2024. Archived from the original on 28 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. 1 2 "Fymskina PI". Union Register of medicinal products. 26 September 2024. Retrieved 30 September 2024.
  9. 1 2 "Summary Basis of Decision for Jamteki". Health Canada . 1 September 2012. Archived from the original on 23 July 2024. Retrieved 23 July 2024.
  10. 1 2 3 4 5 "Otulfi EPAR". European Medicines Agency. 25 July 2024. Archived from the original on 28 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. 1 2 "Otulfi PI". Union Register of medicinal products. 26 September 2024. Retrieved 30 September 2024.
  12. 1 2 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf
  13. 1 2 3 4 5 "Pyzchiva EPAR". European Medicines Agency. 22 February 2024. Archived from the original on 23 February 2024. Retrieved 23 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. 1 2 "Pyzchiva PI". Union Register of medicinal products. 24 April 2024. Retrieved 30 September 2024.
  15. 1 2 3 4 "Steqeyma EPAR". European Medicines Agency. 27 June 2024. Archived from the original on 30 June 2024. Retrieved 12 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. 1 2 "Steqeyma Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
  17. 1 2 "Uzpruvo EPAR". European Medicines Agency. 9 November 2023. Archived from the original on 9 January 2024. Retrieved 14 January 2024.
  18. 1 2 3 "Wezlana APMDS". Therapeutic Goods Administration (TGA). 30 January 2024. Archived from the original on 8 February 2024. Retrieved 7 March 2024.
  19. 1 2 3 4 "Wezenla EPAR". European Medicines Agency . 25 April 2024. Archived from the original on 6 August 2024. Retrieved 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  20. 1 2 "Wezenla PI". Union Register of medicinal products. 22 June 2024. Archived from the original on 26 June 2024. Retrieved 26 June 2024.
  21. ↑ "Ustekinumab (Stelara) Use During Pregnancy". Drugs.com. 26 November 2019. Archived from the original on 22 May 2020. Retrieved 6 April 2020.
  22. ↑ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 31 March 2024. Retrieved 31 March 2024.
  23. ↑ "Regulatory Decision Summary for Stelara". Health Canada . 16 June 2020. Retrieved 28 August 2024.
  24. 1 2 3 4 "Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC)". (emc). 27 February 2020. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  25. 1 2 3 4 5 6 "Stelara- ustekinumab injection, solution Stelara- ustekinumab solution". DailyMed. 24 March 2020. Archived from the original on 2 July 2019. Retrieved 6 April 2020.
  26. 1 2 3 4 5 6 7 8 "Stelara EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  27. 1 2 3 "Ustekinumab". The American Society of Health-System Pharmacists. Archived from the original on 2 February 2017. Retrieved 8 January 2017.
  28. ↑ Cingoz O (2009). "Ustekinumab". mAbs. 1 (3): 216–221. doi:10.4161/mabs.1.3.8593. PMC   2726595 . PMID   20069753.
  29. 1 2 "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". Healio.com. Archived from the original on 9 September 2019. Retrieved 26 September 2019.
  30. ↑ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. 26 October 2017. Archived from the original on 18 April 2019. Retrieved 4 October 2019.
  31. ↑ Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH (September 2008). "Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study". The Lancet. Neurology. 7 (9): 796–804. doi:10.1016/S1474-4422(08)70173-X. PMID   18703004. S2CID   20290673.
  32. ↑ Reddy M, Davis C, Wong J, Marsters P, Pendley C, Prabhakar U (May 2007). "Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12- and IL-23-induced cytokine secretion by CNTO 1275". Cellular Immunology. 247 (1): 1–11. doi:10.1016/j.cellimm.2007.06.006. PMID   17761156.
  33. ↑ Toussirot E (April 2012). "The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases". Inflammation & Allergy - Drug Targets. 11 (2): 159–168. doi:10.2174/187152812800392805. PMID   22280236.
  34. ↑ "Important Safety Information". Stelara (ustekinumab). Janssen Biotech. 22 May 2019. Archived from the original on 29 March 2021. Retrieved 31 December 2010.
  35. ↑ "Highlights of Prescribing Information" (PDF). U.S. Food and Drug Administration. Retrieved 20 August 2024.
  36. ↑ Weber J, Keam SJ (2009). "Ustekinumab". BioDrugs. 23 (1): 53–61. doi:10.2165/00063030-200923010-00006. PMID   19344192. S2CID   265771199.
  37. ↑ Koutruba N, Emer J, Lebwohl M (April 2010). "Review of ustekinumab, an interleukin-12 and interleukin-23 inhibitor used for the treatment of plaque psoriasis". Therapeutics and Clinical Risk Management. 6: 123–141. doi: 10.2147/tcrm.s5599 . PMC   2857612 . PMID   20421912.
  38. ↑ "FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application" (Press release). Centocor. 25 September 2009. Archived from the original on 6 April 2020. Retrieved 6 April 2020– via Drugs.com.
  39. ↑ "Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis". Archived from the original on 1 August 2013. Retrieved 16 December 2008.
  40. ↑ "New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 31 December 2022. Retrieved 5 August 2024.
  41. ↑ "Summary Basis of Decision for Stelara". Health Canada . 27 May 2009. Retrieved 28 August 2024.
  42. ↑ "Stelara Product information". Health Canada . 5 January 2009. Archived from the original on 5 August 2024. Retrieved 5 August 2024.
  43. ↑ "Stelara approved for moderate to severe psoriasis. Sept 2009". 26 September 2009. Archived from the original on 20 September 2015. Retrieved 6 July 2010.
  44. ↑ "Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  45. ↑ "Stelara (ustekinumab) Injection NDA #761044". U.S. Food and Drug Administration (FDA). 12 January 2018. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  46. ↑ "12 Sept 2017". Archived from the original on 15 March 2021. Retrieved 4 October 2019.
  47. ↑ "Janssen's Stelara Gets FDA Approval for Ulcerative Colitis". FDA News. Archived from the original on 13 January 2020. Retrieved 31 October 2019.
  48. ↑ "Stelara: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 20 October 2020. Retrieved 6 April 2020.
  49. 1 2 3 4 "Uzpruvo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 10 November 2023. Retrieved 13 November 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  50. ↑ "Uzpruvo Product information". Union Register of medicinal products. 8 January 2024. Archived from the original on 10 January 2024. Retrieved 14 January 2024.
  51. ↑ "Regulatory Decision Summary for Jamteki". Health Canada . 9 November 2023. Retrieved 28 August 2024.
  52. ↑ "Summary Basis of Decision for Wezlana/Wezlana I.V." Health Canada . 1 September 2012. Retrieved 28 August 2024.
  53. ↑ "Regulatory Decision Summary for Wezlana/Wezlana I.V." Health Canada . 27 December 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  54. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). 26 April 2024. Archived from the original on 5 July 2024. Retrieved 13 June 2024.
  55. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". European Medicines Agency. 28 June 2024. Archived from the original on 12 July 2024. Retrieved 12 July 2024.
  56. ↑ "Regulatory Decision Summary for Steqeyma/Steqeyma IV". Health Canada . 30 July 2024. Retrieved 28 August 2024.
  57. ↑ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". Health Canada . 7 August 2024. Retrieved 28 August 2024.
  58. ↑ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". Health Canada . 7 August 2024. Retrieved 28 August 2024.
  59. ↑ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf
  60. ↑ "US FDA Approves Dong-A ST's Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara" (Press release). Dong-A ST. 11 October 2024. Retrieved 14 October 2024– via Business Wire.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.