Chemistry:Ustekinumab

From HandWiki

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,[1] targeting both IL-12 and IL-23.[2] It is administered either by intravenous infusion or subcutaneous injection.[1] 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.[3] Ustekinumab was developed by Centocor Ortho Biotech.[4]

Ustekinumab (an immunosuppressant interleukin inhibitor) [5] is a fully human IgG1κ monoclonal antibody that binds to the shared p40 protein subunit of interleukin (IL) 12 and 23, thereby preventing them from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells.[5] By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.[5]

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.[6][7][8][9] It was found not effective for multiple sclerosis.[10] It is on the World Health Organization's List of Essential Medicines.[11]

Medical uses

Ustekinumab is used to treat psoriasis.[6] This includes psoriatic arthritis when it affects the skin.[1][6] 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.[6][12] It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.[6]

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);[7] active psoriatic arthritis in adults;[7] moderately to severely active Crohn's disease in adults;[7] and moderately to severely active ulcerative colitis in adults.[7]

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.[6] Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.[13]

Pregnancy

It is unknown if the medication is safe during pregnancy or breastfeeding.[14]

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.[15]

History

In December 2007, a biologic license application with the US Food and Drug Administration (FDA) was filed by Centocor;[4][16] 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, recommending to grant a marketing authorization for the medicinal product Stelara, 45 mg or 90 mg powder for solution for injection, intended for the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to, or who have a contraindication to, or who are intolerant to other systemic therapies including cyclosporine, methotrexate and psoralen plus ultra- violet A light [PUVA]).[7] The applicant for this medicinal product is Janssen-Cilag International NV.[7]

Society and culture

Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.[17] In September 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis.[18]

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.[19][20]

Ustekinumab was authorized for medical use in the European Union in January 2009.[7][21]

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.[22][4]

The FDA approved ustekinumab in September 2016, to treat Crohn's disease.[23]

Since September 2017, ustekinumab has been available on the AU Pharmaceutical Benefits Scheme to treat severe Crohn's disease in adults.[24]

In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[8][7]

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[25][26]

Biosimilars

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States.[27][28]

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,[29] psoriatic arthritis and Crohn's disease in adults.[29] The applicant for this medicinal product is STADA Arzneimittel AG.[29] Uzpruvo is a biosimilar medicinal product.[29] Uzpruvo was authorized for medical use in the European Union in January 2024.[30][31]

In November 2023, Jamteki was approved for medical use in Canada.[32][33][34]

In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada.[35][36]

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.[37] The applicant for this medicinal product is Samsung Bioepis NL B.V.[37] Pyzchiva is a biosimilar medicinal product.[37] Pyzchiva was authorized for medical use in the European Union in April 2024.[37][38]

Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024.[39][28]

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.[40][41] The applicant for this medicinal product is Amgen Technology (Ireland) UC.[40] Wezenla was authorized for medical use in the European Union in June 2024.[40][42]

Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024.[43][28]

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.[44][45] The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.[44] Steqeyma was authorized for medical use in the European Union in August 2024.[44][46]

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.[47] The applicant for this medicinal product is Samsung Bioepis NL B.V.[47] Eksunbi is a biosimilar medicinal product.[47] Eksunbi is a biosimilar medicinal product.[47] Eksunbi was authorized for medical use in the European Union in September 2024.[47][48]

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.[49] The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.[49] Otulfi is a biosimilar medicinal product.[49] Otulfi was authorized for medical use in the European Union in September 2024.[49][50]

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.[51] The applicant for this medicinal product is Formycon AG.[51] Fymskina is a biosimilar medicinal product.[51] Fymskina was authorized for medical use in the European Union in September 2024.[51][52]

In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada.[53]

In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada.[54][55]

Steqeyma was approved for medical use in Australia in September 2024.[56]

In September 2024, ustekinumab-aauz (Otulfi) was approved for medical use in the United States.[57][58][28]

Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024.[59][60][28]

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.[61] The applicant for this medicinal product is Accord Healthcare S.L.U.[61] Absimky is a biosimilar medicinal product.[61][62] Absimky was authorized for medical use in the European Union in December 2024.[63]

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.[64] The applicant for this medicinal product is Accord Healthcare S.L.U.[64] Imuldosa is a biosimilar medicinal product.[64] Imuldosa was authorized for medical use in the European Union in December 2024.[65]

Ustekinumab-kfce (Yesintek) was approved for medical use in the United States in December 2024.[66][28]

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.[67] The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.[67] Yesintek is a biosimilar medicinal product that is highly similar to the reference product Stelara, which was authorized in the EU in January 2009.[67]

Ustekinumab-stba (Steqeyma) was approved for medical use in the United States in December 2024.[68][28]

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.[69] The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.[69] Qoyvolma is a biosimilar medicinal product that is highly similar to the reference product Stelara.[69] Qoyvolma was authorized for medical use in the EU in June 2025.[69][70]

Ustekinumab-hmny, (Starjemza) was approved for medical use in the United States in May 2025.[71]

In June 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Usymro, intended for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease.[72] The applicant for this medicinal product is ELC Group s.r.o.[72] Usymro is a biosimilar medicinal product that is highly similar to the reference product Stelara.[72]

In July 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Usrenty, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.[73] The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.[73] Usrenty is a biosimilar medicinal product that is highly similar to the reference product Stelara.[73] Usrenty was authorized for medical use in the EU in June 2025.[73][74]

In September 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Usgena, intended for the treatment of adults and children with plaque psoriasis, and adults with psoriatic arthritis, Crohn's disease, and ulcerative colitis.[5] The applicant for this medicinal product is STADA Arzneimittel AG.[5] Usgena is a biosimilar medicinal product that is highly similar to the reference product Stelara.[5] Usgena was authorized for medical use in the European Union in November 2025.[5][75]

References

  1. ↑ 1.0 1.1 1.2 "Ustekinumab". The American Society of Health-System Pharmacists. https://www.drugs.com/monograph/ustekinumab.html. 
  2. ↑ "Ustekinumab". mAbs 1 (3): 216–221. 2009. doi:10.4161/mabs.1.3.8593. PMID 20069753. 
  3. ↑ "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. May 2007. doi:10.1016/j.cellimm.2007.06.006. PMID 17761156. 
  4. ↑ 4.0 4.1 4.2 "Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261". 24 December 1999. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm. 
  5. ↑ 5.0 5.1 5.2 5.3 5.4 5.5 5.6 "Usgena EPAR". 19 September 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/usgena.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ↑ 6.0 6.1 6.2 6.3 6.4 6.5 "Stelara- ustekinumab injection, solution Stelara- ustekinumab solution". 24 March 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b. 
  7. ↑ 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 "Stelara EPAR". https://www.ema.europa.eu/en/medicines/human/EPAR/stelara.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ↑ 8.0 8.1 "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". 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. 
  9. ↑ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. 26 October 2017. https://www.nps.org.au/radar/articles/ustekinumab-stelara-pbs-listed-for-severe-crohns-disease. 
  10. ↑ "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. September 2008. doi:10.1016/S1474-4422(08)70173-X. PMID 18703004. 
  11. ↑ The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list. Geneva: World Health Organization. 2025. 
  12. ↑ "The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases". Inflammation & Allergy - Drug Targets 11 (2): 159–168. April 2012. doi:10.2174/187152812800392805. PMID 22280236. 
  13. ↑ "Ustekinumab". BioDrugs 23 (1): 53–61. 2009. doi:10.2165/00063030-200923010-00006. PMID 19344192. 
  14. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Stelara SmPC
  15. ↑ "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. April 2010. doi:10.2147/tcrm.s5599. PMID 20421912. 
  16. ↑ "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.
  17. ↑ "Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis". http://news.idsk.com/viewer/story.php?CLIENT=INFOMAILER&NEWSID=prn121520081223240607. 
  18. ↑ "New Drug Therapy Approvals 2022". 31 December 2022. https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022. 
  19. ↑ "Summary Basis of Decision for Stelara". 27 May 2009. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00140. 
  20. ↑ "Stelara Product information". 5 January 2009. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80608. 
  21. ↑ "Stelara Product information". 20 January 2009. https://ec.europa.eu/health/documents/community-register/html/h494.htm. 
  22. ↑ "Stelara approved for moderate to severe psoriasis. Sept 2009". 26 September 2009. http://www.empr.com/stelara-approved-for-moderate-to-severe-psoriasis/article/149760/. 
  23. ↑ "Stelara (ustekinumab) Injection NDA #761044". 12 January 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm. 
  24. ↑ "12 Sept 2017". https://www.pbs.gov.au/medicine/item/10767Q-10774C-11164N-11178H-11182M-9304Q-9305R. 
  25. ↑ "Janssen's Stelara Gets FDA Approval for Ulcerative Colitis". https://www.fdanews.com/articles/193283-janssens-stelara-gets-fda-approval-for-ulcerative-colitis. 
  26. ↑ "Stelara: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761044. 
  27. ↑ "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. Public Domain This article incorporates text from this source, which is in the public domain.
  28. ↑ 28.0 28.1 28.2 28.3 28.4 28.5 28.6 "Biosimilar Drug Information". 1 October 2024. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. 
  29. ↑ 29.0 29.1 29.2 29.3 "Uzpruvo: Pending EC decision". 10 November 2023. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/uzpruvo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  30. ↑ "Uzpruvo EPAR". 9 November 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/uzpruvo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  31. ↑ "Uzpruvo Product information". 8 January 2024. https://ec.europa.eu/health/documents/community-register/html/h1784.htm. 
  32. ↑ "Summary Basis of Decision for Jamteki". 1 September 2012. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1718291599089. 
  33. ↑ "Regulatory Decision Summary for Jamteki". 9 November 2023. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702060641808. 
  34. ↑ "Regulatory Decision Summary for Jamteki / Jamteki I.V.". 9 November 2023. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734360561368. 
  35. ↑ "Summary Basis of Decision for Wezlana/Wezlana I.V.". 1 September 2012. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721675750511. 
  36. ↑ "Regulatory Decision Summary for Wezlana/Wezlana I.V.". 27 December 2023. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125. 
  37. ↑ 37.0 37.1 37.2 37.3 "Pyzchiva EPAR". 22 February 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/pyzchiva.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  38. ↑ "Pyzchiva Product information". 24 April 2024. https://ec.europa.eu/health/documents/community-register/html/h1801.htm. 
  39. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Selarsdi PR
  40. ↑ 40.0 40.1 40.2 "Wezenla EPAR". 25 April 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  41. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (EMA) (Press release). 26 April 2024. Archived from the original on 5 July 2024. Retrieved 13 June 2024.
  42. ↑ "Wezenla Product information". 22 June 2024. https://ec.europa.eu/health/documents/community-register/html/h1823.htm. 
  43. ↑ "Archived copy". https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s000,761425s000lbl.pdf. 
  44. ↑ 44.0 44.1 44.2 "Steqeyma EPAR". 27 June 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/steqeyma.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  45. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". 28 June 2024. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-24-27-june-2024. 
  46. ↑ "Steqeyma Product information". 23 August 2024. https://ec.europa.eu/health/documents/community-register/html/h1844.htm. 
  47. ↑ 47.0 47.1 47.2 47.3 47.4 "Eksunbi EPAR". 25 July 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/Eksunbi.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  48. ↑ "Eksunbi Product information". 13 September 2024. https://ec.europa.eu/health/documents/community-register/html/h1858.htm. 
  49. ↑ 49.0 49.1 49.2 49.3 "Otulfi EPAR". 25 July 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/otulfi.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  50. ↑ "Otulfi Product information". 26 September 2024. https://ec.europa.eu/health/documents/community-register/html/h1863.htm. 
  51. ↑ 51.0 51.1 51.2 51.3 "Fymskina EPAR". 25 July 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/fymskina.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  52. ↑ "Fymskina Product information". 26 September 2024. https://ec.europa.eu/health/documents/community-register/html/h1862.htm. 
  53. ↑ "Regulatory Decision Summary for Steqeyma/Steqeyma IV". 30 July 2024. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095. 
  54. ↑ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". 7 August 2024. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724776566772. 
  55. ↑ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". 7 August 2024. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724778020977. 
  56. ↑ "Steqeyma (Ustekinumab)". 1 November 2024. https://www.tga.gov.au/resources/auspmd/steqeyma-ustekinumab. 
  57. ↑ fda.gov
  58. ↑ fda.gov
  59. ↑ "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.
  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.
  61. ↑ 61.0 61.1 61.2 "Absimky EPAR". 17 October 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/absimky.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  62. ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024". 18 October 2024. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2024. 
  63. ↑ "Absimky Product information". 13 December 2024. https://ec.europa.eu/health/documents/community-register/html/h1880.htm. 
  64. ↑ 64.0 64.1 64.2 "Imuldosa EPAR". 17 October 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/imuldosa.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  65. ↑ "Imuldosa Product information". 16 December 2024. https://ec.europa.eu/health/documents/community-register/html/h1872.htm. 
  66. ↑ "U.S. FDA Approves Biocon Biologics' Yesintek, Bmab 1200 Biosimilar to J&J's Stelara (Ustekinumab)". Biocon Biologics. 2 December 2024. https://www.prnewswire.com/news-releases/us-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab-302319272.html. 
  67. ↑ 67.0 67.1 67.2 "Yesintek EPAR". 12 December 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/yesintek.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  68. ↑ "Steqeyma- ustekinumab injection, solution". 23 December 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=66085e17-e3f2-4196-8c81-87448e804b0c. 
  69. ↑ 69.0 69.1 69.2 69.3 "Qoyvolma EPAR". 27 March 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/qoyvolma.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  70. ↑ "Qoyvolma Product information". 13 June 2025. https://ec.europa.eu/health/documents/community-register/html/h1925.htm. 
  71. ↑ "Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection" (Press release). Hikma. 27 May 2025. Retrieved 29 May 2025 – via PR Newswire.
  72. ↑ 72.0 72.1 72.2 "Usymro EPAR". 20 June 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/usymro.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  73. ↑ 73.0 73.1 73.2 73.3 "Usrenty EPAR". 25 July 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/usrenty.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  74. ↑ "Usrenty Product information". 26 September 2025. https://ec.europa.eu/health/documents/community-register/html/h1973.htm. 
  75. ↑ "Usgena PI". 18 November 2025. https://ec.europa.eu/health/documents/community-register/html/h1987.htm. 



Retrieved from "https://handwiki.org/wiki/index.php?title=Chemistry:Ustekinumab&oldid=4306031"