ustekinumab
{{Short description|Biopharmaceutical drug}}
{{Use dmy dates|date=July 2024}}
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{{Infobox drug
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| type = mab
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| mab_type = mab
| source = u
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| tradename = Stelara
| Drugs.com = {{drugs.com|monograph|ustekinumab}}
| MedlinePlus = a611013
| DailyMedID = Ustekinumab
| pregnancy_AU = B1
| pregnancy_AU_comment = {{cite web | title=Ustekinumab (Stelara) Use During Pregnancy | website=Drugs.com | date=26 November 2019 | url=https://www.drugs.com/pregnancy/ustekinumab.html | access-date=6 April 2020 | archive-date=22 May 2020 | archive-url=https://web.archive.org/web/20200522084941/https://www.drugs.com/pregnancy/ustekinumab.html | url-status=live }}
| pregnancy_category =
| routes_of_administration = Subcutaneous, intravenous
| class = Immunosuppressant interleukin inhibitor
| ATC_prefix = L04
| ATC_suffix = AC05
| ATC_supplemental =
| biosimilars = ustekinumab-aauz, ustekinumab-aekn,{{cite press release | title=Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab) | publisher=Alvotech | via=GlobeNewswire | date=16 April 2024 | url=https://www.globenewswire.com/news-release/2024/04/16/2864156/0/en/Alvotech-and-Teva-Announce-U-S-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab.html | access-date=17 April 2024 | archive-date=17 April 2024 | archive-url=https://web.archive.org/web/20240417034634/https://www.globenewswire.com/news-release/2024/04/16/2864156/0/en/Alvotech-and-Teva-Announce-U-S-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab.html | url-status=live }} ustekinumab-auub, ustekinumab-hmny, ustekinumab-kfce, ustekinumab-srlf, ustekinumab-stba, ustekinumab-ttwe, Absimky, Eksunbi, Fymskina, Imuldosa, Jamteki, Otulfi, Pyzchiva, Selarsdi, Starjemza, Steqeyma, Uzpruvo, Wezlana, Wezenla, Yesintek
| legal_AU = S4
| legal_AU_comment = {{cite web | title=Wezlana APMDS | website=Therapeutic Goods Administration (TGA) | date=30 January 2024 | url=https://www.tga.gov.au/resources/auspmd/wezlana | access-date=7 March 2024 | archive-date=8 February 2024 | archive-url=https://web.archive.org/web/20240208064947/https://www.tga.gov.au/resources/auspmd/wezlana | url-status=live }}{{cite web | title=Prescription medicines and biologicals: TGA annual summary 2017 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/resources/publication/publications/prescription-medicines-and-biologicals-tga-annual-summary-2017 | access-date=31 March 2024 | archive-date=31 March 2024 | archive-url=https://web.archive.org/web/20240331021323/https://www.tga.gov.au/resources/publication/publications/prescription-medicines-and-biologicals-tga-annual-summary-2017 | url-status=live }}
| legal_BR =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = /{{nbsp}}Schedule D{{cite web | title=Regulatory Decision Summary for Stelara | website=Health Canada | date=16 June 2020 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00665 | access-date=28 August 2024}}
| legal_DE =
| legal_DE_comment =
| legal_NZ =
| legal_NZ_comment =
| legal_UK = POM
| legal_US = Rx-only
| legal_EU = Rx-only
| legal_UN =
| legal_UN_comment =
| legal_status = Rx-only
| bioavailability =
| protein_bound =
| metabolites =
| onset =
| elimination_half-life = 15–32 days (average 3 weeks)
| duration_of_action =
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| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 815610-63-0
| CAS_supplemental =
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB05679
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
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| UNII = FU77B4U5Z0
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D09214
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201835
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = CNTO 1275
| IUPAC_name =
| C=6482 | H=10004 | N=1712 | O=2016 | S=46
| SMILES =
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Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23.{{cite journal | vauthors = Cingoz O | title = Ustekinumab | journal = mAbs | volume = 1 | issue = 3 | pages = 216–221 | year = 2009 | pmid = 20069753 | pmc = 2726595 | doi = 10.4161/mabs.1.3.8593 }} It is administered either by intravenous infusion or subcutaneous injection. 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.{{cite journal | vauthors = Reddy M, Davis C, Wong J, Marsters P, Pendley C, Prabhakar U | title = Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12- and IL-23-induced cytokine secretion by CNTO 1275 | journal = Cellular Immunology | volume = 247 | issue = 1 | pages = 1–11 | date = May 2007 | pmid = 17761156 | doi = 10.1016/j.cellimm.2007.06.006 }} Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease. Ustekinumab was developed by Centocor Ortho Biotech.
Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union; and ulcerative colitis in the United States, and in the European Union to people who have not responded to more traditional treatments.{{cite web|title=EC approves expanded use of Stelara for moderately to severely active ulcerative colitis|url=https://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/%7B1092e4c0-15b5-4ba2-871b-3a7930e27283%7D/ec-approves-expanded-use-of-stelara-for-moderately-to-severely-active-ulcerative-colitis|access-date=26 September 2019|website=Healio.com|archive-date=9 September 2019|archive-url=https://web.archive.org/web/20190909060817/https://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/%7B1092e4c0-15b5-4ba2-871b-3a7930e27283%7D/ec-approves-expanded-use-of-stelara-for-moderately-to-severely-active-ulcerative-colitis|url-status=live}}{{cite news|title=Ustekinumab (Stelara) PBS listed for severe Crohn's disease|url=https://www.nps.org.au/radar/articles/ustekinumab-stelara-pbs-listed-for-severe-crohns-disease|access-date=4 October 2019|newspaper=NPS Medicinewise|date=26 October 2017|archive-date=18 April 2019|archive-url=https://web.archive.org/web/20190418101429/https://www.nps.org.au/radar/articles/ustekinumab-stelara-pbs-listed-for-severe-crohns-disease|url-status=live}} It was found not effective for multiple sclerosis.{{cite journal | vauthors = Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH | title = 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 | journal = The Lancet. Neurology | volume = 7 | issue = 9 | pages = 796–804 | date = September 2008 | pmid = 18703004 | doi = 10.1016/S1474-4422(08)70173-X | s2cid = 20290673 }}
Medical uses
Ustekinumab is used to treat psoriasis.{{cite web | title=Stelara- ustekinumab injection, solution Stelara- ustekinumab solution | website=DailyMed | date=24 March 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b | access-date=6 April 2020 | archive-date=2 July 2019 | archive-url=https://web.archive.org/web/20190702163317/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b | url-status=live }} This includes psoriatic arthritis when it affects the skin.{{cite web|title=Ustekinumab|url=https://www.drugs.com/monograph/ustekinumab.html|publisher=The American Society of Health-System Pharmacists|access-date=8 January 2017|archive-date=2 February 2017|archive-url=https://web.archive.org/web/20170202064829/https://www.drugs.com/monograph/ustekinumab.html|url-status=live}} 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.{{cite journal | vauthors = Toussirot E | title = The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases | journal = Inflammation & Allergy - Drug Targets | volume = 11 | issue = 2 | pages = 159–168 | date = April 2012 | pmid = 22280236 | doi = 10.2174/187152812800392805 }} It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.
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); active psoriatic arthritis in adults; moderately to severely active Crohn's disease in adults; and moderately to severely active ulcerative colitis in adults.{{cite web | title=Stelara EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/stelara | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406181137/https://www.ema.europa.eu/en/medicines/human/EPAR/stelara | url-status=live }}
Adverse effects
The most common side effects include upper respiratory tract infection, headache, fatigue, nausea, vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, fever, and diarrhea. Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.{{cite journal | vauthors = Weber J, Keam SJ | title = Ustekinumab | journal = BioDrugs | volume = 23 | issue = 1 | pages = 53–61 | year = 2009 | pmid = 19344192 | doi = 10.2165/00063030-200923010-00006 | s2cid = 265771199 }}
= Pregnancy =
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.{{cite journal | vauthors = Koutruba N, Emer J, Lebwohl M | title = Review of ustekinumab, an interleukin-12 and interleukin-23 inhibitor used for the treatment of plaque psoriasis | journal = Therapeutics and Clinical Risk Management | volume = 6 | pages = 123–141 | date = April 2010 | pmid = 20421912 | pmc = 2857612 | doi = 10.2147/tcrm.s5599 | doi-access = free }}
History
In December 2007, a biologic license application with the US Food and Drug Administration (FDA) was filed by Centocor;{{cite press release | title=FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application | via=Drugs.com | publisher=Centocor | date=25 September 2009 | url=https://www.drugs.com/nda/ustekinumab_081219.html | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183734/https://www.drugs.com/nda/ustekinumab_081219.html | url-status=live }} and Janssen-Cilag International (collaborator) submitted a marketing authorization application to the European Medicines Agency (EMA). In November 2008, the Committee for Medicinal Products for Human Use 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.
Society and culture
= Legal status =
Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.{{Cite web |url=http://news.idsk.com/viewer/story.php?CLIENT=INFOMAILER&NEWSID=prn121520081223240607 |title=Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis |access-date=16 December 2008 |archive-date=1 August 2013 |archive-url=https://web.archive.org/web/20130801043325/http://news.idsk.com/viewer/story.php?CLIENT=INFOMAILER&NEWSID=prn121520081223240607 |url-status=live }} In September 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis.{{cite web | title=New Drug Therapy Approvals 2022 | website=U.S. Food and Drug Administration (FDA) | date=31 December 2022 | url=https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022 | access-date=5 August 2024}}
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.{{cite web | title=Summary Basis of Decision for Stelara | website=Health Canada | date=27 May 2009 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00140 | access-date=28 August 2024}}{{cite web | title=Stelara Product information | website=Health Canada | date=5 January 2009 | url=https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80608 | access-date=5 August 2024 | archive-date=5 August 2024 | archive-url=https://web.archive.org/web/20240805051647/https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80608 | url-status=live }}
The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.{{Cite web |url=http://www.empr.com/stelara-approved-for-moderate-to-severe-psoriasis/article/149760/ |title=Stelara approved for moderate to severe psoriasis. Sept 2009 |date=26 September 2009 |access-date=6 July 2010 |archive-date=20 September 2015 |archive-url=https://web.archive.org/web/20150920021419/http://www.empr.com/stelara-approved-for-moderate-to-severe-psoriasis/article/149760/ |url-status=live }}{{cite web | title=Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261 | website=U.S. Food and Drug Administration (FDA) | date=24 December 1999 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183104/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm | url-status=dead }}
The FDA approved ustekinumab in September 2016, to treat Crohn's disease.{{cite web | title=Stelara (ustekinumab) Injection NDA #761044 | website=U.S. Food and Drug Administration (FDA) | date=12 January 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm | access-date=6 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406183450/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm | url-status=live }}
Since September 2017, ustekinumab has been available on the AU Pharmaceutical Benefits Scheme to treat severe Crohn's disease in adults.{{Cite web |url=https://www.pbs.gov.au/medicine/item/10767Q-10774C-11164N-11178H-11182M-9304Q-9305R |title=12 Sept 2017 |access-date=4 October 2019 |archive-date=15 March 2021 |archive-url=https://web.archive.org/web/20210315000734/https://www.pbs.gov.au/medicine/item/10767Q-10774C-11164N-11178H-11182M-9304Q-9305R |url-status=live }}
In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis.
In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.{{cite web |title=Janssen's Stelara Gets FDA Approval for Ulcerative Colitis |url=https://www.fdanews.com/articles/193283-janssens-stelara-gets-fda-approval-for-ulcerative-colitis |website=FDA News |access-date=31 October 2019 |archive-date=13 January 2020 |archive-url=https://web.archive.org/web/20200113205721/https://www.fdanews.com/articles/193283-janssens-stelara-gets-fda-approval-for-ulcerative-colitis |url-status=live }}{{cite web | title=Stelara: FDA-Approved Drugs | website=U.S. Food and Drug Administration (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761044 | access-date=6 April 2020 | archive-date=20 October 2020 | archive-url=https://web.archive.org/web/20201020044734/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761044 | url-status=dead }}
== Biosimilars ==
{{see also|Biosimilars}}
In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States.{{cite press release | title=FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases | website=U.S. Food and Drug Administration | date=31 October 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases | access-date=13 November 2023 | archive-date=13 November 2023 | archive-url=https://web.archive.org/web/20231113104806/https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases | url-status=live }} {{PD-notice}}{{cite web | title=Biosimilar Drug Information | website=U.S. Food and Drug Administration (FDA) | date=1 October 2024 | url=https://www.fda.gov/drugs/biosimilars/biosimilar-product-information | access-date=2 December 2024}}
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, psoriatic arthritis and Crohn's disease in adults. The applicant for this medicinal product is STADA Arzneimittel AG. Uzpruvo is a biosimilar medicinal product.{{cite web | title=Uzpruvo: Pending EC decision | website=European Medicines Agency (EMA) | date=10 November 2023 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/uzpruvo | access-date=13 November 2023 | archive-date=10 November 2023 | archive-url=https://web.archive.org/web/20231110192548/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/uzpruvo | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Uzpruvo was authorized for medical use in the European Union in January 2024.{{cite web | title=Uzpruvo EPAR | website=European Medicines Agency | date=9 November 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo | access-date=14 January 2024 | archive-date=9 January 2024 | archive-url=https://web.archive.org/web/20240109150917/https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo | url-status=live }}{{cite web | title=Uzpruvo Product information | website=Union Register of medicinal products | date=8 January 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1784.htm | access-date=14 January 2024 | archive-date=10 January 2024 | archive-url=https://web.archive.org/web/20240110084759/https://ec.europa.eu/health/documents/community-register/html/h1784.htm | url-status=live }}
In November 2023, Jamteki was approved for medical use in Canada.{{cite web | title=Summary Basis of Decision for Jamteki | website=Health Canada | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089 | access-date=23 July 2024 | archive-date=23 July 2024 | archive-url=https://web.archive.org/web/20240723044300/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089 | url-status=live }}{{cite web | title=Regulatory Decision Summary for Jamteki | website=Health Canada | date=9 November 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702060641808 | access-date=28 August 2024}}{{cite web | title=Regulatory Decision Summary for Jamteki / Jamteki I.V. | website=Drug and Health Products Portal | date=9 November 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734360561368 | access-date=27 December 2024}}
In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada.{{cite web | title=Summary Basis of Decision for Wezlana/Wezlana I.V. | website=Health Canada | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721675750511 | access-date=28 August 2024}}{{cite web | title=Regulatory Decision Summary for Wezlana/Wezlana I.V. | website=Health Canada | date=27 December 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125 | access-date=2 April 2024 | archive-date=2 April 2024 | archive-url=https://web.archive.org/web/20240402043205/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125 | url-status=live }}
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. The applicant for this medicinal product is Samsung Bioepis NL B.V.{{cite web | title=Pyzchiva EPAR | website=European Medicines Agency | date=22 February 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva | access-date=23 February 2024 | archive-date=23 February 2024 | archive-url=https://web.archive.org/web/20240223132607/https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Pyzchiva is a biosimilar medicinal product. Pyzchiva was authorized for medical use in the European Union in April 2024.{{cite web | title=Pyzchiva PI | website=Union Register of medicinal products | date=24 April 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1801.htm | access-date=30 September 2024}}
Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024.
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.{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 | website=European Medicines Agency | date=26 April 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 | access-date=13 June 2024 | archive-date=5 July 2024 | archive-url=https://web.archive.org/web/20240705192841/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024 | url-status=live }} The applicant for this medicinal product is Amgen Technology (Ireland) UC.{{cite web | title=Wezenla EPAR | website=European Medicines Agency | date=25 April 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla | access-date=27 April 2024 | archive-date=6 August 2024 | archive-url=https://web.archive.org/web/20240806000155/https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Wezenla was authorized for medical use in the European Union in June 2024.{{cite web | title=Wezenla PI | website=Union Register of medicinal products | date=22 June 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1823.htm | access-date=26 June 2024 | archive-date=26 June 2024 | archive-url=https://web.archive.org/web/20240626062648/https://ec.europa.eu/health/documents/community-register/html/h1823.htm | url-status=live }}
Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024.{{Cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s000,761425s000lbl.pdf |title=Archived copy |access-date=2 July 2024 |archive-date=2 July 2024 |archive-url=https://web.archive.org/web/20240702044715/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s000,761425s000lbl.pdf |url-status=live }}
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.{{cite web | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024 | website=European Medicines Agency | date=28 June 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 | access-date=12 July 2024 | archive-date=12 July 2024 | archive-url=https://web.archive.org/web/20240712152232/https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024 | url-status=live }} The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.{{cite web | title=Steqeyma EPAR | website=European Medicines Agency | date=27 June 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma | access-date=12 July 2024 | archive-date=30 June 2024 | archive-url=https://web.archive.org/web/20240630134223/https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Steqeyma was authorized for medical use in the European Union in August 2024.{{cite web | title=Steqeyma Product information | website=Union Register of medicinal products | date=23 August 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1844.htm | access-date=27 August 2024}}
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. The applicant for this medicinal product is Samsung Bioepis NL B.V. Eksunbi is a biosimilar medicinal product.{{cite web | title=Eksunbi EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Eksunbi | access-date=29 July 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Eksunbi is a biosimilar medicinal product. Eksunbi was authorized for medical use in the European Union in September 2024.{{cite web | title=Eksunbi Product information | website=Union Register of medicinal products | date=13 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1858.htm | access-date=17 September 2024}}
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. The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH. Otulfi is a biosimilar medicinal product.{{cite web | title=Otulfi EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi | access-date=27 July 2024 | archive-date=28 July 2024 | archive-url=https://web.archive.org/web/20240728125816/https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Otulfi was authorized for medical use in the European Union in September 2024.{{cite web | title=Otulfi PI | website=Union Register of medicinal products | date=26 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1863.htm | access-date=30 September 2024}}
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. The applicant for this medicinal product is Formycon AG. Fymskina is a biosimilar medicinal product.{{cite web | title=Fymskina EPAR | website=European Medicines Agency | date=25 July 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina | access-date=27 July 2024 | archive-date=28 July 2024 | archive-url=https://web.archive.org/web/20240728062424/https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Fymskina was authorized for medical use in the European Union in September 2024.{{cite web | title=Fymskina PI | website=Union Register of medicinal products | date=26 September 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1862.htm | access-date=30 September 2024}}
In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada.{{cite web | title=Regulatory Decision Summary for Steqeyma/Steqeyma IV | website=Health Canada | date=30 July 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095 | access-date=28 August 2024}}
In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada.{{cite web | title=Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab) | website=Health Canada | date=7 August 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724776566772 | access-date=28 August 2024}}{{cite web | title=Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab) | website=Health Canada | date=7 August 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724778020977 | access-date=28 August 2024}}
Steqeyma was approved for medical use in Australia in September 2024.{{cite web | title=Steqeyma (Ustekinumab) | website=Therapeutic Goods Administration (TGA) | date=1 November 2024 | url=https://www.tga.gov.au/resources/auspmd/steqeyma-ustekinumab | access-date=19 December 2024}}
In September 2024, ustekinumab-aauz (Otulfi) was approved for medical use in the United States.[https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf fda.gov][https://web.archive.org/web/20241001151352/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf fda.gov]
Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024.{{cite press release | title=FDA Approves Imuldosa (ustekinumab-srlf), Accord BioPharma's Biosimilar to Stelara (ustekinumab), for the Treatment of Chronic Inflammatory Conditions | publisher=Accord BioPharma | via=PR Newswire | date=14 October 2024 | url=https://www.prnewswire.com/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302274563.html | access-date=14 October 2024}}{{cite press release | title=US FDA Approves Dong-A ST's Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara | publisher=Dong-A ST | via=Business Wire | date=11 October 2024 | url=https://www.businesswire.com/news/home/20241011360476/en/US-FDA-Approves-Dong-A-ST%E2%80%99s-IMULDOSA%E2%84%A2-ustekinumab-srlf-a-Biosimilar-to-STELARA%C2%AE | access-date=14 October 2024}}
In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Absimky, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease, or ulcerative colitis. The applicant for this medicinal product is Accord Healthcare S.L.U.{{cite web | title=Absimky EPAR | website=European Medicines Agency (EMA) | date=17 October 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/absimky | access-date=19 October 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Absimky is a biosimilar medicinal product.{{cite web | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024 | website=European Medicines Agency (EMA) | date=18 October 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2024 | access-date=21 October 2024}} Absimky was authorized for medical use in the European Union in December 2024.{{cite web | title=Absimky PI | website=Union Register of medicinal products | date=13 December 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1880.htm | access-date=19 December 2024}}
In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imuldosa, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease. The applicant for this medicinal product is Accord Healthcare S.L.U. Imuldosa is a biosimilar medicinal product.{{cite web | title=Imuldosa EPAR | website=European Medicines Agency (EMA) | date=17 October 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/imuldosa | access-date=19 October 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Imuldosa was authorized for medical use in the European Union in December 2024.{{cite web | title=Imuldosa Product information | website=Union Register of medicinal products | date=16 December 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1872.htm | access-date=17 December 2024}}
Ustekinumab-kfce (Yesintek) was approved for medical use in the United States in December 2024.{{cite web | title=U.S. FDA Approves Biocon Biologics' Yesintek, Bmab 1200 Biosimilar to J&J's Stelara (Ustekinumab) | publisher=Biocon Biologics | via=PR Newswire | date=2 December 2024 | url=https://www.prnewswire.com/news-releases/us-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab-302319272.html | access-date=2 December 2024}}
In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yesintek, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease. The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited. Yesintek is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in January 2009.{{cite web | title=Yesintek EPAR | website=European Medicines Agency (EMA) | date=12 December 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/yesintek | access-date=16 December 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Ustekinumab-stba (Steqeyma) was approved for medical use in the United States in December 2024.{{cite web | title=Steqeyma- ustekinumab injection, solution | website=DailyMed | date=23 December 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66085e17-e3f2-4196-8c81-87448e804b0c | access-date=25 January 2025}}
In March 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Qoyvolma, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease or ulcerative colitis. The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. Qoyvolma is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in January 2009.{{cite web | title=Qoyvolma EPAR | website=European Medicines Agency (EMA) | date=27 March 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/qoyvolma | access-date=28 March 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Ustekinumab-hmny, (Starjemza) was approved for medical use in the United States in May 2025.{{cite press release | title=Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection | publisher=Hikma | via=PR Newswire | date=27 May 2025 | url=https://www.prnewswire.com/news-releases/bio-thera-solutions-and-hikma-pharmaceuticals-announce-fda-approval-of-starjemza-ustekinumab-hmny-injection-a-biosimilar-referencing-stelara-ustekinumab-injection-302465299.html | access-date=29 May 2025}}
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Category:Drugs developed by Johnson & Johnson