Drugs / Ustekinumab
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Crohn jejunoileitis 2 milestones | |||||
| Filed | US (FDA) | STELARA | Crohn jejunoileitis | 2015-11-30 | “Janssen Submits Applications Seeking Approval of Stelara® in United States and European Union for Crohn's Disease” jnj.com ↗ |
| Filed | EU (EMA) | STELARA | Crohn jejunoileitis | 2015-11-30 | “Janssen Submits Applications Seeking Approval of Stelara® in United States and European Union for Crohn's Disease” jnj.com ↗ |
| Filed juvenile ankylosing spondylitis 1 milestone | |||||
| Filed | US (FDA) | STELARA | juvenile ankylosing spondylitis | 2021-10-08 | “Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis” jnj.com ↗ |
| Filed psoriasis 2 milestones | |||||
| Filed | US (FDA) | STELARA | psoriasis | 2019-10-07 | “STELARA (ustekinumab) - Janssen Submits Application to U.S. FDA for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (U.S.)” jnj.com ↗ |
| Filed | EU (EMA) | STELARA | psoriasis | 2014-10-10 | “Janssen also submitted a marketing application this year to the European Medicines Agency seeking approval of STELARA as a treatment for pediatric PsO patients.” jnj.com ↗ “filed with the European Medicines Agency seeking approval of STELARA® (ustekinumab) for the treatment of moderate to severe plaque psoriasis” jnj.com ↗ |
| Filed psoriatic arthritis 1 milestone | |||||
| Filed | EU (EMA) | STELARA | psoriatic arthritis | — | “a Type II Variation to the European Medicines Agency requesting approval of STELARA ® (ustekinumab)” jnj.com ↗ |
| Filed ulcerative colitis 1 milestone | |||||
| Filed | EU (EMA) | STELARA | ulcerative colitis | 2019-01-07 | “JANSSEN SUBMITS APPLICATION TO EUROPEAN MEDICINES AGENCY SEEKING APPROVAL OF STELARA® (USTEKINUMAB) FOR TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (9) | US (FDA) | STELARA | — | 2009-12-30 – 2026-04-15 | fda.gov ↗ |
| Approved | US (FDA) | STELARA | — | 2009-09-25 | fda.gov ↗ |
| Approved | EU (EMA) | Stelara | — | 2009-01-16 | europa.eu ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06742606 | Jan 2025 → Apr 2026 overdue | — | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04549792 | Apr 2021 → Jan 2024 | ichthyosis | Northwestern University | Completed | No outcome recorded |
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT05725876 | Jan 2025 → Jul 2026 overdue | Crohn disease, psoriasis | University Medical Center Groningen | Recruiting | No outcome recorded |
| Phase 1 | NCT05890118 | Aug → Nov 2023 | — | RANI Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05252533 | May 2022 → Jan 2024 | psoriasis, psoriasis-related juvenile idiopathic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04744363 | May 2021 → Mar 2022 | psoriasis | Alvotech Swiss AG | Completed | Met primary |
| Phase 1 | NCT04772274 | Feb 2021 → Apr 2022 | — | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04093531 | Jan 2020 → May 2022 | Sjogren syndrome | University of Rochester | Completed | No outcome recorded |
| Phase 1 | NCT04030533 | Nov 2019 → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03358706 | Feb 2018 → Nov 2021 | Crohn disease, ulcerative colitis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT02968108 | Jan 2017 → Sep 2018 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02156375 | May → Dec 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01276847 | Mar → Dec 2011 | psoriasis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01081704 | Oct 2009 → Jun 2010 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1/25 trials · 1 missed | ||||||
| Phase 1/2 | NCT03366142 | Jul 2018 → Oct 2024 | leukocyte adhesion deficiency 1 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT02955147 | Dec 2016 → Jul 2019 | temporal arteritis | Massachusetts General Hospital | Terminated | Missed primary |
| Phase 1/2 | NCT02199496 | Oct 2015 → Aug 2019 | diarrhea, glucose-stimulated secretory, with common variable immunodeficiency, gastrointestinal mucositis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT02117765 | Mar 2015 → Feb 2017 | type 1 diabetes mellitus | University of British Columbia | Unknown | No outcome recorded |
| Phase 1/2 | NCT01647152 | Jul 2012 → Jun 2015 | uveitis | National Eye Institute (NEI) | Withdrawn | No outcome recorded |
| Phase 230 trials · 5 met primary · 5 missed | ||||||
| Phase 2 | NCT07268534 | Apr 2026 → Nov 2029 expected | Quinquaud's folliculitis decalvans | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06807593 | Feb 2026 → Mar 2027 expected | cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06453317 | Feb 2025 → Apr 2028 expected | ulcerative colitis | Medical University of Lodz | Recruiting | No outcome recorded |
| Phase 2 | NCT07582991 | Mar 2024 → Feb 2026 | Behcet disease, myelodysplastic syndrome | Liu Tian | Completed | No outcome recorded |
| Phase 2 | NCT04572815 | May 2021 → Oct 2025 overdue | hematopoietic and lymphoid system neoplasm | Fred Hutchinson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03651518 | Oct 2020 → Nov 2025 | autoimmune disease, inflammatory disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT04117932 | Mar 2020 → Dec 2022 | bullous pemphigoid | Reims University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03847272 | Aug 2019 → Oct 2023 | — | Centre Hospitalier Universitaire Dijon | Terminated | No outcome recorded |
| Phase 2 | NCT03881059 | Apr 2019 → Apr 2020 | psoriatic arthritis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 2 | NCT03711448 | Jan 2019 → Sep 2024 | temporal arteritis | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 2 | NCT02648581 | Jun 2017 → May 2019 | Behcet disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02911116 | Mar 2017 → Mar 2020 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT02877134 | Aug 2016 → Dec 2020 | Crohn disease | Janssen Research & Development, LLC | Completed | Mixed |
| Phase 2 | NCT02204397 | Nov 2015 → Mar 2017 | type 1 diabetes mellitus | Jewish General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02349061 | Oct 2015 → May 2017 | systemic lupus erythematosus | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01999868 | Mar 2014 → Dec 2017 | psoriasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01945086 | Sep 2013 → Dec 2014 | atopic eczema | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT01806662 | Mar 2013 → Mar 2015 | atopic eczema | Rockefeller University | Completed | No outcome recorded |
| Phase 2 | NCT01713400 | Feb 2013 → Oct 2014 | graft versus host disease | H. Lee Moffitt Cancer Center and Research Institute | Completed | Missed primary |
| Phase 2 | NCT01645280 | Aug 2012 → Dec 2013 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01704534 | May 2012 → Jan 2014 | hidradenitis suppurativa | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT01330901 | Oct 2011 → Apr 2013 | ankylosing spondylitis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT01389973 | Sep 2011 → Jun 2013 | primary biliary cholangitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00955279 | Nov 2009 → May 2012 | sarcoidosis | Centocor, Inc. | Completed | Missed primary |
| Phase 2 | NCT00771667 | Dec 2008 → May 2010 | Crohn disease | Centocor, Inc. | Completed | Met primary |
| Phase 2 | NCT00267956 | Dec 2005 → Mar 2007 | psoriatic arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 2 | NCT00207727 | Jul 2004 → Mar 2006 | multiple sclerosis | Centocor, Inc. | Completed | Missed primary |
| Phase 2 | NCT00265122 | Apr 2004 → Nov 2005 | Crohn disease | Centocor, Inc. | Completed | Missed primary |
| Phase 2 | NCT00320216 | Nov 2003 → Jun 2004 | psoriasis | Centocor, Inc. | Completed | Met primary |
| Phase 2/33 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05535738 | Nov 2022 → Jan 2027 expected | allergic contact dermatitis | Wei-Che Ko | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03941132 | Jan 2021 → Feb 2026 overdue | type 1 diabetes mellitus | University of British Columbia | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03466411 | Apr 2018 → Oct 2023 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 336 trials · 15 met primary · 6 missed | ||||||
| Phase 3 | NCT05083182 | Aug 2022 → Jan 2026 overdue | arthritic joint disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05092269 | Oct 2021 → Sep 2027 expected | Crohn disease, psoriatic arthritis, ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04882072 | Sep 2021 → May 2023 | Takayasu arteritis | Janssen Pharmaceutical K.K. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05299931 | Sep 2021 → Jun 2026 overdue | Crohn disease | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04673357 | Apr 2021 → Nov 2024 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04761627 | Mar 2021 → Feb 2023 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT04630028 | Mar 2021 → May 2025 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04632927 | Dec 2020 → Oct 2024 | psoriatic arthritis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04607980 | Nov 2020 → Jan 2022 | psoriasis | Amgen | Completed | Met primary |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT04060888 | Jul 2020 → Jan 2022 | systemic lupus erythematosus | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT04435600 | Jul 2020 → Feb 2024 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04089345 | Jun 2020 → Dec 2022 | pouchitis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 3 | NCT03981744 | Jul 2019 → Jan 2022 | dermatomyositis | Janssen Pharmaceutical K.K. | Terminated | Missed primary |
| Phase 3 | NCT03782376 | Dec 2018 → Aug 2022 | Crohn disease | Janssen-Cilag Ltd. | Completed | Missed primary |
| Phase 3 | NCT03517722 | Apr 2018 → Nov 2020 | systemic lupus erythematosus | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 3 | NCT03464136 | Mar 2018 → Dec 2020 | Crohn disease | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 3 | NCT03107793 | Apr 2017 → Apr 2020 | Crohn disease | Janssen-Cilag Ltd. | Completed | Missed primary |
| Phase 3 | NCT02698475 | May 2016 → Dec 2017 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02437162 | Sep 2015 → Mar 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 3 | NCT02438787 | Jul 2015 → Aug 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02407223 | Jul 2015 → Sep 2017 | ankylosing spondylitis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02407236 | Jul 2015 → Aug 2018 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02203032 | Oct 2014 → Dec 2015 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01550744 | Mar 2012 → May 2015 | psoriasis | Janssen Biotech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01369355 | Sep 2011 → Jun 2015 | Crohn disease, colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01369329 | Jul 2011 → Jun 2013 | Crohn disease, colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01369342 | Jul 2011 → Aug 2014 | Crohn disease, colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01090427 | May 2010 → Jan 2013 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01077362 | Mar 2010 → Mar 2012 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01009086 | Dec 2009 → Oct 2011 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01008995 | Oct 2009 → Jul 2011 | psoriasis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00747344 | Dec 2008 → Sep 2009 | psoriasis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00454584 | Mar 2007 → Jan 2008 | psoriasis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00267969 | Dec 2005 → Jul 2006 | psoriasis | Centocor Research & Development, Inc. | Completed | Met primary |
| Phase 3 | NCT00307437 | May 2005 → Dec 2006 | psoriasis | Centocor Research & Development, Inc. | Completed | Met primary |
| Phase 416 trials | ||||||
| Phase 4 | NCT07576452 | Dec 2026 → Jun 2030 expected | ulcerative colitis | University Hospital, Clermont-Ferrand | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07303686 | Oct 2025 → Apr 2027 expected | Crohn disease, ulcerative colitis | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | No outcome recorded |
| Phase 4 | NCT06788340 | Sep 2025 → Aug 2027 expected | Crohn disease, ulcerative colitis | Odense University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06045754 | Apr 2024 → Jun 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT05861167 | Jun 2023 → Jun 2024 | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 4 | NCT05270733 | Nov 2022 → Dec 2026 expected | psoriasis | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05169593 | Sep 2022 → Oct 2027 expected | Crohn disease | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04629196 | Feb 2022 → Jan 2024 | Crohn disease | NYU Langone Health | Terminated | No outcome recorded |
| Phase 4 | NCT05029921 | Dec 2021 → May 2025 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT04996485 | Mar 2021 → Mar 2023 | inherited ichthyosis | National Medical Research Center for Children's Health, Russian Federation | Unknown | No outcome recorded |
| Phase 4 | NCT04496063 | Nov 2020 → Jun 2025 overdue | perianal Crohn disease | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02693470 | Aug 2014 → Jul 2016 | psoriasis | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01511315 | Mar 2012 → Dec 2014 | psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT01059773 | Oct 2009 → Nov 2010 | psoriasis | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07529236 | Apr 2026 → Oct 2027 expected | inflammatory bowel disease | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| — | NCT06912815 | Aug 2024 → Sep 2026 overdue | Crohn disease | Xiang Gao | Recruiting | No outcome recorded |
| — | NCT03712826 | Jul 2022 | Crohn disease | Hospices Civils de Lyon | Withdrawn | No outcome recorded |
| — | NCT01090063 | Feb 2010 → Feb 2012 | psoriasis | Tufts Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03362736 | — | Crohn disease | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| Comparator or background therapy48 trials | ||||||
| Phase 1 | NCT06481215 Comparator | Mar → Sep 2022 | — | AO GENERIUM | Completed | No outcome recorded |
| Phase 1 | NCT04371185 Comparator | Aug 2020 → Apr 2021 | psoriasis | Bio-Thera Solutions | Completed | Met primary |
| Phase 1 | NCT04428814 Comparator | Aug 2020 → Feb 2021 | — | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT02763969 Background | May → Dec 2016 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT03167437 Comparator | Oct 2017 → Jun 2035 expected | Crohn disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT04978493 Background | Dec 2021 → Jul 2024 | Crohn disease | Boehringer Ingelheim | Terminated | Missed primary |
| Phase 2 | NCT04655807 Background | Mar 2021 → May 2023 | Crohn disease | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02319759 Background | Mar 2015 → May 2016 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT02054481 Comparator | Feb → Nov 2014 | psoriasis | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT07177118 Comparator | Oct 2025 → Jun 2028 expected | Crohn disease | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07116967 Comparator | Sep 2025 → Jan 2031 expected | psoriasis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07149467 Comparator | Sep 2025 → Dec 2026 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06934226 Comparator | Apr → Nov 2025 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06274554 Background | Oct 2024 → Dec 2028 expected | Crohn disease | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 3 | NCT06425549 Comparator | Jun 2024 → Aug 2028 expected | psoriasis | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06488664 Comparator | Jul 2023 → Apr 2025 | psoriasis | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT04305327 Comparator | Dec 2022 → May 2023 | psoriasis | LEO Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05335356 Comparator | Jun 2022 → Jan 2023 | psoriasis | Biocon Biologics UK Ltd | Completed | Met primary |
| Phase 3 | NCT04728360 Comparator | Jul 2021 → Oct 2022 | psoriasis | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 3 | NCT04967508 Comparator | Jul 2021 → Feb 2022 | psoriasis | Samsung Bioepis Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04930042 Comparator | Jun → Dec 2021 | psoriasis | Alvotech Swiss AG | Completed | Met primary |
| Phase 3 | NCT04785326 Comparator | Apr 2021 → Feb 2022 | psoriasis | Dong-A ST Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04673786 Comparator | Jan → Aug 2021 | psoriasis | Celltrion | Completed | Met primary |
| Phase 3 | NCT04595409 Comparator | Nov 2020 → Jun 2021 | psoriasis | Bioeq GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04524611 Comparator | Sep 2020 → Feb 2028 expected | Crohn disease | AbbVie | Active not recruiting | Met primary |
| Phase 3 | NCT04505410 Comparator | Sep 2020 → Dec 2023 | ulcerative colitis | University of Miami | Completed | No outcome recorded |
| Phase 3 | NCT04245215 Comparator | Mar 2020 → Sep 2024 | Crohn disease | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW | Completed | No outcome recorded |
| Phase 3 | NCT03926130 Comparator | Jul 2019 → Aug 2023 | Crohn disease | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT03370133 Comparator | Dec 2017 → Jan 2019 | psoriasis, psoriatic arthritis | UCB Biopharma SRL | Completed | Met primary |
| Phase 3 | NCT03148860 Comparator | Dec 2016 → Apr 2021 | psoriatic arthritis | Dr. Frank Behrens | Completed | No outcome recorded |
| Phase 3 | NCT02826603 Comparator | Jun 2016 → Jul 2018 | psoriasis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02684357 Comparator | Mar → Dec 2016 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02684370 Comparator | Feb → Dec 2016 | psoriasis | AbbVie | Completed | Met primary |
| Phase 3 | NCT02561806 Comparator | Oct 2015 → May 2016 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT02074982 Comparator | Feb 2014 → Jun 2016 | psoriasis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01708629 Comparator | Sep 2012 → Aug 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT02786732 Comparator | Aug 2012 → Jun 2017 | psoriasis | MedDerm Associates | Terminated | No outcome recorded |
| Phase 3 | NCT01708603 Comparator | Aug 2012 → Sep 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | Met primary Stop: Business |
| Phase 3 | NCT01091051 Comparator | Mar 2010 → Aug 2011 | palmoplantar pustulosis | Innovaderm Research Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00723528 Comparator | Mar 2008 → Jan 2009 | psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 4 | NCT06520397 Comparator | Jul 2024 → Dec 2026 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT05928039 Comparator | Oct 2023 → Jul 2027 expected | Crohn disease | University of Calgary | Recruiting | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03629379 Comparator | Jan 2019 → Jan 2021 | inflammatory bowel disease, psoriasis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT02187172 Comparator | Jul 2014 → Sep 2018 | cardiovascular disorder, psoriasis | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT02144857 Comparator | May 2014 → Sep 2023 | psoriasis | University of Athens | Unknown | No outcome recorded |
| Phase 4 | NCT01558310 Comparator | Aug 2012 → Oct 2013 | psoriasis | Paul Steven Yamauchi, MD, PhD | Unknown | No outcome recorded |
| — | NCT04779762 Background | Jan 2022 → Jan 2025 | Crohn disease | Wolfson Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 136
| Date | Issuer | Release |
|---|---|---|
| 2026-05-22 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - USTEKINUMAB INJECTION RECEIVES MARKETING AUTHORISATION FROM NMPA irasia.com ↗
Ustekinumab Injection (brand name: Enyike ( 恩益克®)) (the ‘‘Product ’’) developed by the Group has received marketing authorisation from the National Medical Products Administ ration of the People ’s Republic of China (‘‘NMPA ’’). |
| 2026-05-05 | AbbVie | Results AbbVie Highlights New Long-Term Data Advancing Treatment Standards in Inflammatory Bowel Diseases (IBD) at 2026 Digestive Disease Week® abbvie.com ↗
It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab. |
| 2026-05-01 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces FDA Approval of STELARA® for Pediatric Crohn’s Disease jnj.com ↗
On April 15, 2026, the U.S. Food and Drug Administration (FDA) approved STELARA®(ustekinumab) for the treatment of patients two years and older with moderately to severely active Crohn’s disease (CD). |
| 2026-02-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years jnj.com ↗
Primary safety results from the UNITI Jr study of STELARA®(ustekinumab) showing that it was effective and well-tolerated, with no new safety signals, in treating pediatric patients with Crohn’s disease. |
| 2026-02-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years jnj.com ↗ |
| 2025-12-23 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 자가면역질환 치료제 일본 품목허가 승인 samsungbioepis.com ↗
삼성바이오에피스(대표이사 김경아 사장)가 일본 후생노동성으로부터 자가면역질환 치료제 스텔라라(Stelara)1) 바이오시밀러(프로젝트명 SB17, 성분명 우스테키누맙)의 품목 허가를 획득했다. |
| 2025-12-18 | Celltrion | Regulatory Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector celltrion.com ↗
SteQeyma™ 45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD) |
| 2025-10-31 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to U.S. FDA for STELARA® (ustekinumab) in the treatment of pediatric ulcerative colitis jnj.com ↗ |
| 2025-08-27 | Gedeon Richter Ltd. | Regulatory The European Commission approves Bio-Thera’s BAT2206 (USYMRO®, a biosimilar ustekinumab), to be commercialized by Richter in Europe gedeonrichter.com ↗
Gedeon Richter announces today that the European Commission (EC) granted marketing authorization for BAT2206 (ustekinumab), a biosimilar – developed by Bio-Thera Solutions Inc. (“Bio-Thera”) – referencing Stelara®. |
| 2025-06-17 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval of STELARA® (ustekinumab) for the treatment of pediatric Crohn’s disease jnj.com ↗ |
| 2025-06-16 | Celltrion | Regulatory Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients celltrion.com ↗
Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. |
| 2025-05-27 | Roxane Laboratories | Regulatory Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection hikma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA® (ustekinumab-hmny ) Injection, a biosimilar referencing Stelara® (ustekinumab) Injection. |
| 2025-05-19 | Formycon AG | Regulatory Formycon and Fresenius Kabi announce FDA Approval of Interchangeability for FYB202/Otulfi® (ustekinumab-aauz) formycon.com ↗
Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its commercialization partner Fresenius Kabi announce today that the U.S. Food and Drug Administration (FDA) designated FYB202/Otulfi ®1 (ustekinumab-aauz) as interchangeable with the reference biologic Stelara ®2 (ustekinumab). |
| 2025-05-15 | Intas Pharmaceuticals, Ltd. | Regulatory Accord BioPharma, Inc. Announces U.S. FDA Acceptance of Biologics License Application for Proposed STELARA Biosimilar intaspharma.com ↗
Accord BioPharma, Inc. the U.S. specialty division of Intas Pharmaceuticals Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115. |
| 2025-05-05 | Alvotech Swiss AG | Regulatory Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab) alvotech.com ↗
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 |
| 2025-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab) tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). |
| 2025-04-10 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 국내 학회서 자가면역질환 치료제 최신 연구 성과 공개 samsungbioepis.com ↗
연구 결과 우스테키누맙 성분 의약품 바이오시밀러 도입으로 예상되는 의료 비용 절감 효과는 3년간 독일에서 총 4억4천만 유로(약 6,500억원), 영국에서 4,950만 유로(약 730억원), 스웨덴에서 3,680만 유로(약 150억원)로 추산되어5), 바이오시밀러 처방에 따른 비용 절감 가능성을 확인할 수 있었다. |
| 2025-02-20 | Formycon AG | Results Formycon presents clinical data on ustekinumab biosimilar FYB202 at the ECCO Congress in Berlin formycon.com ↗
The therapeutic equivalence of FYB202 was demonstrated in a Phase I pharmacokinetics (PK) study in 491 healthy volunteers and in a Phase III efficacy study in 392 patients with moderate to severe plaque psoriasis. |
| 2025-01-15 | Formycon AG | Regulatory Formycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara® formycon.com ↗
Otulfi ® received MHRA approval for both subcutaneous and intravenous formulations, to treat serious inflammatory diseases |
| 2025-01-08 | Formycon AG | Regulatory Formycon and Fresenius Kabi Canada receive Health Canada’s approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara® formycon.com ↗ |
| 2025-01-07 | Biocon Biologics UK Ltd | Regulatory Japan Health Authority (PMDA) Approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J’s Stelara® bioconbiologics.com ↗
Biocon Biologics Ltd (BBL) , a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has approved Ustekinumab BS subcutaneous injection [YD], a biosimilar to the reference product, Stelara® ( Ustekinumab ). |
| 2024-12-30 | Intas Pharmaceuticals, Ltd. | Regulatory FDA Approves IMULDOSA (ustekinumab-srlf), Accord BioPharma's Biosimilar to STELARA intaspharma.com ↗
The FDA approved IMULDOSA for all indications of its reference medicine, STELARA. |
| 2024-12-18 | Celltrion | Regulatory U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) celltrion.com ↗ |
| 2024-12-01 | Biocon Biologics UK Ltd | Regulatory U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab) bioconbiologics.com ↗
YESINTEK™ , a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. |
| 2024-11-26 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF BIOLOGIC LICENSE APPLICATION OF USTEKINUMAB INJECTION irasia.com ↗
The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that the biologic license application of Ustekinumab Injection (th e ‘‘Product ’’) developed by CSPC Megalith Biopharmaceutical Co., Ltd ( 石藥集團巨石生物製藥有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People ’s Republic of China. |
| 2024-11-13 | Alvotech Swiss AG | Regulatory Alvotech Reports Financial Results for the First Nine Months of 2024 alvotech.com ↗
Alvotech and Teva Pharmaceuticals announced that the U.S. FDA has approved a new presentation of SELARSDI™ (ustekinumab-aekn), a biosimilar to Stelara® (ustekinumab), in a 130 mg/26 mL single-dose vial for intravenous infusion. |
| 2024-10-22 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. |
| 2024-10-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab) tevapharm.com ↗ |
| 2024-10-10 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis jnj.com ↗
Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled endoscopic endpoints. |
| 2024-10-10 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn's disease and ulcerative colitis jnj.com ↗
Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled endoscopic endpoints. |
| 2024-10-10 | Intas Pharmaceuticals, Ltd. | Regulatory Accord Healthcare receives positive CHMP opinion for IMULDOSA, ustekinumab biosimilar to Stelara intaspharma.com ↗
The CHMP ’s positive opinion paves the way for the authorization of Imuldosa® in the EU ustekinumab market, valued at approximately €2.9 billion (US$3.18 billion) according to IQVIA MAT June 2024 data. |
| 2024-09-30 | Fresenius Kabi | Regulatory U.S. FDA Approval for OtulfiTM*, an Ustekinumab Biosimilar fresenius.com ↗
After having received the European Commission approval just recently, Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the United States (U.S.) Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara®** (ustekinumab). |
| 2024-09-30 | Fresenius Kabi | Regulatory Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar OtulfiTM* (ustekinumab-aauz) Otulfi™ received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara®. fresenius-kabi.com ↗ |
| 2024-09-30 | Formycon AG | Regulatory Formycon and Fresenius Kabi receive FDA approval for FYB202/Otulfi™ (ustekinumab-aauz) formycon.com ↗
Otulfi TM received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara ® |
| 2024-09-27 | Fresenius Kabi | Regulatory European Commission Approval for FYB202, an Ustekinumab Biosimilar fresenius.com ↗
Fresenius, via its operating company Fresenius Kabi, and its license partner Formycon announced that the European Commission (EC) granted marketing authorization for FYB202, a biosimilar candidate to Stelara® (ustekinumab) indicated for the treatment of several serious inflammatory diseases. |
| 2024-09-27 | Fresenius Kabi | Regulatory Otulfi®*, Fresenius Kabi’s Ustekinumab Biosimilar Developed by Formycon, Receives European Commission Approval Otulfi® received European Commission (EC) approval for both subcutaneous and intravenous formulations, providing a high-quality treatment option for European patients treated with ustekinumab fresenius-kabi.com ↗ |
| 2024-09-27 | Formycon AG | Regulatory Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases formycon.com ↗ |
| 2024-09-27 | Formycon AG | Regulatory FDA grants approval for Stelara® Biosimilar FYB202/Otulfi™ (ustekinumab-aauz) formycon.com ↗
Formycon AG (FSE: FYB, “Formycon“) announces that the U.S. Food and Drug Administration (“FDA”) today approved FYB202/Otulfi TM1 (ustekinumab-aauz), a biosimilar to Stelara ®2 . |
| 2024-09-17 | Formycon AG | Results Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna formycon.com ↗
The randomized, double-blind, multicenter VESPUCCI Phase III study met the primary endpoint, demonstrating similar efficacy of FYB202 and the reference drug Stelara ® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). |
| 2024-08-26 | Celltrion | Regulatory European Commission approves Celltrion’s SteQeyma® (CT-P43), a biosimilar to Stelara® (ustekinumab), for the treatment of multiple chronic inflammatory diseases celltrion.com ↗
Celltrion today announced that the European Commission (EC) has approved the use of SteQeyma® (CT-P43), an ustekinumab biosimilar referencing Stelara®, for the treatment of multiple chronic inflammatory diseases. |
| 2024-07-26 | Fresenius Kabi | Regulatory Positive CHMP Opinion for FYB202, an Ustekinumab Biosimilar Candidate fresenius.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB202 |
| 2024-07-26 | Fresenius Kabi | Regulatory Fresenius Kabi and Formycon Receive Positive CHMP Opinion for FYB202, an Ustekinumab Biosimilar Candidate
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases. fresenius-kabi.com ↗
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends approval of FYB202 for the treatment of severe inflammatory diseases in the fields of gastroenterology, dermatology, and rheumatology |
| 2024-07-26 | Formycon AG | Regulatory Stelara® Biosimilar Candidate FYB202 (Ustekinumab) receives positive CHMP opinion from EMA formycon.com ↗
Formycon AG (FSE: FYB, “Formycon“) announces that the Committee for Medicinal Products for Human Use („CHMP“) of the European Medicines Agency („EMA“) today issued a positive opinion for FYB202, a biosimilar candidate to Stelara ®1 (Ustekinumab). |
| 2024-07-26 | Formycon AG | Regulatory Formycon and Fresenius Kabi receive positive CHMP opinion for FYB202 (Ustekinumab), a biosimilar candidate to Stelara® formycon.com ↗ |
| 2024-07-02 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 자가면역질환 치료제 '피즈치바'(SB17) 미국 허가 획득 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)가 미국 식품의약국(FDA: Food and Drug Administration)으로부터 스텔라라(Stelara)1) 바이오시밀러 '피즈치바(PYZCHIVA®, 프로젝트명 SB17, 성분명 우스테키누맙)'의 품목허가를 획득했다고 2일 밝혔다. |
| 2024-07-01 | Sandoz | Regulatory FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by Sandoz in US sandoz.com ↗
Pyzchiva® (ustekinumab-ttwe) is approved by FDA for all indications of reference medicine |
| 2024-05-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates superiority versus STELARA® (ustekinumab) in Phase 3 Crohn’s disease program jnj.com ↗
In results versus ustekinumab, both doses of TREMFYA®demonstrated statistically significant and clinically meaningful differences on all prespecified pooled endoscopic endpoints. |
| 2024-05-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates superiority versus STELARA® (ustekinumab) in Phase 3 Crohn’s disease program jnj.com ↗
The GALAXI 2 (n=508) and GALAXI 3 (n=513) studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in CD. |
| 2024-04-21 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 자가면역질환 치료제 '피즈치바'(SB17) 유럽 허가 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)가 유럽연합 집행위원회(EC: European Commission)로부터 스텔라라(Stelara)1) 바이오시밀러 '피즈치바(PYZCHIVATM, 프로젝트명 SB17, 성분명 우스테키누맙)'의 품목 허가를 최종 획득했다고 23일 밝혔다. |
| 2024-04-16 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab) alvotech.com ↗ |
| 2024-04-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab) tevapharm.com ↗ |
| 2024-04-12 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 스텔라라 바이오시밀러 '에피즈텍®(EPYZTEK®)' 국내 품목 허가 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)는 11일, 식품의약품안전처로부터 자가면역질환 치료제 '스텔라라(Stelara)1)' 바이오시밀러(동등생물의약품) '에피즈텍®(EPYZTEK®, 프로젝트명 SB17, 성분명 우스테키누맙)'의 품목허가를 국내 최초로 획득했다. |
| 2024-03-10 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 미국 피부과 학회(AAD)에서 자가면역질환 치료제 2종 연구 결과 발표 samsungbioepis.com ↗
또한, 삼성바이오에피스는 SB17의 임상 3상 52주 최종 결과도 발표했다. |
| 2024-02-25 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 자가면역질환 치료제 '피즈치바'(SB17) 유럽 허가 권고 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)가 유럽 의약품청(EMA: European Medicines Agency) 산하 약물사용 자문위원회(CHMP: Committee for Medicinal Products for Human Use)로부터 스텔라라(Stelara)1) 바이오시밀러 '피즈치바(PYZCHIVATM, 프로젝트명 SB17, 성분명 우스테키누맙)'의 판매 허가 긍정 의견(positive opinion)을 획득했다. |
| 2024-02-22 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽서 자가면역질환 치료제(SB17) 후속 연구 결과 발표 samsungbioepis.com ↗
삼성바이오에피스가 학술대회를 통해 공개한 첫 번째 초록(abstract)은 SB17과 오리지널 의약품 간 구조적(structural), 물리화학적 (physicochemical), 생물리학적(biophysical), 생물학적(biological) 특성을 분석한 것이며, 연구 결과 모든 측면에서의 동등성을 확인했다. |
| 2024-02-05 | RANI Therapeutics | Results Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111) ranitherapeutics.com ↗
Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar, CT-P43. |
| 2024-01-10 | Alvotech Swiss AG | Regulatory STADA and Alvotech Secure Approval for Uzpruvo, Europe’s First Ustekinumab Biosimilar to Stelara alvotech.com ↗
Partners STADA and Alvotech today announced that the European Commission issued a marketing authorization for Uzpruvo® (AVT04), a biosimilar candidate to Stelara® (ustekinumab). |
| 2023-11-30 | Fresenius Kabi | Regulatory Fresenius Kabi and Formycon announce FDA submission acceptance for review for Ustekinumab biosimilar candidate fresenius.com ↗
Fresenius Kabi and its license partner Formycon announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB202, a Ustekinumab biosimilar candidate. |
| 2023-11-30 | Fresenius Kabi | Regulatory Fresenius Kabi and Formycon Announce FDA Submission Acceptance for Review for Ustekinumab Biosimilar Candidate
Announcement of Fresenius Kabi and its license partner Formycon: FDA has accepted Ustekinumab biosimilar candidate for review. fresenius-kabi.com ↗
Fresenius Kabi and its license partner Formycon announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB202, a Ustekinumab biosimilar candidate. |
| 2023-11-30 | Formycon AG | Regulatory Formycon and Fresenius Kabi announce File Acceptance for FYB202, a biosimilar candidate to Stelara® (ustekinumab), by the U.S. Food and Drug Administration formycon.com ↗ |
| 2023-11-14 | Alvotech Swiss AG | Regulatory Alvotech and JAMP Pharma Announce Receipt of Marketing Authorization for Jamteki (AVT04), the First Biosimilar of Stelara® (ustekinumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech. |
| 2023-11-10 | Alvotech Swiss AG | Regulatory STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara alvotech.com ↗
Partners STADA and Alvotech today announced that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency’s (EMA) has adopted a positive opinion for Uzpruvo (AVT04), a biosimilar candidate to Stelara® (ustekinumab). |
| 2023-10-16 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study jnj.com ↗
46.0 percent (29/63)1 |
| 2023-10-15 | AbbVie | Results AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints abbvie.com ↗ |
| 2023-10-12 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽 피부과학회서 자가면역질환 치료제(SB17) 임상 3상 결과 발표 samsungbioepis.com ↗
삼성바이오에피스는 지난해 11월 국내 환자를 포함하여 글로벌 8개국에서 503명의 중등도 내지 중증의 판상 건선 환자를 대상으로 SB17의 임상 3상을 완료했으며, 금번 연구 결과를 통해 오리지널 의약품 간 유효성(efficacy)과 안전성(safety) 등의 임상의학적 동등성을 확인했다. |
| 2023-09-29 | Fresenius Kabi | Regulatory EMA has accepted marketing authorization application for Ustekinumab biosimilar candidate of Fresenius Kabi and Formycon fresenius.com ↗
Fresenius Kabi and its license partner Formycon announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for FYB202, an Ustekinumab biosimilar candidate. |
| 2023-09-29 | Fresenius Kabi | Regulatory Fresenius Kabi and Formycon Announce EMA Submission Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate Fresenius Kabi and its license partner Formycon AG announce that the European Medicines Agency has accepted the Marketing Authorization Application for FYB202. fresenius-kabi.com ↗ |
| 2023-09-29 | Formycon AG | Regulatory Formycon and Fresenius Kabi announce European Medicines Agency Acceptance of the Marketing Authorization Application for FYB202, an Ustekinumab Biosimilar Candidate formycon.com ↗
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its commercialization partner Fresenius Kabi today announced that the European Medicines Agency (“EMA”) has accepted the Marketing Authorization Application (“MAA”) for FYB202, a proposed biosimilar candidate to Stelara ® 1 . |
| 2023-09-25 | Alvotech Swiss AG | Regulatory Alvotech Announces Approval in Japan of AVT04 (ustekinumab), a Biosimilar to Stelara® alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji”), has received marketing approval for AVT04 (ustekinumab), a biosimilar to Stelara®, from the Japanese Ministry of Health, Labor and Welfare. |
| 2023-09-12 | AbbVie | Results AbbVie's SKYRIZI® (risankizumab) Met All Primary and Secondary Endpoints Versus Stelara® (ustekinumab) in Head-to-Head Study in Crohn's Disease abbvie.com ↗
Risankizumab met both primary endpoints of non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24 and superiority of endoscopic remission at week 48 versus ustekinumab |
| 2023-04-25 | Formycon AG | Results Formycon announces successful results of Phase I clinical trial for ustekinumab biosimilar candidate FYB202 and concludes clinical development formycon.com ↗
The positive results of the Phase I pharmacokinetics study successfully conclude the clinical development program. |
| 2023-03-04 | Janssen Research & Development, LLC | Results New STELARA® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis jnj.com ↗ |
| 2023-03-03 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Demonstrates a Differentiated Binding Mechanism from Risankizumab in In Vitro Studies jnj.com ↗
New STELARA® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis |
| 2023-02-09 | Alvotech Swiss AG | Regulatory EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel (STADA) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). |
| 2023-01-06 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) alvotech.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. |
| 2022-10-10 | Janssen Research & Development, LLC | Results STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis jnj.com ↗
At week 200 (four years), this proportion of patients was 55.2 percent; the majority (96.4 percent [185/192]) were not receiving corticosteroids. |
| 2022-10-10 | Janssen Research & Development, LLC | Results STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis jnj.com ↗
At week 200 (four years), this proportion of patients was 55.2 percent; the majority (96.4 percent [185/192]) were not receiving corticosteroids. |
| 2022-08-16 | Formycon AG | Results Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara®* in Phase III Study formycon.com ↗
The multi-center, randomized, double-blinded, comparative clinical study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB202 and the reference medicine Stelara ® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). |
| 2022-08-01 | Janssen Research & Development, LLC | Regulatory STELARA® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved STELARA®(ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). |
| 2022-08-01 | Janssen Research & Development, LLC | Regulatory STELARA® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). |
| 2022-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022 jnj.com ↗
The STELARA pooled analyses of long-term safety data in bio-naïve and bio-failure CD/UC patients treated with STELARA demonstrated a favorable safety profile consistent with analyses in the overall inflammatory bowel disease (IBD) population and the established safety profile across approved indications. |
| 2022-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA® (guselkumab) and Long-Term Safety for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022 jnj.com ↗
Other data presented demonstrate the long-term safety profile of STELARA® (ustekinumab) in bio-naïve and bio-failure patients living with inflammatory bowel disease |
| 2022-05-24 | Alvotech Swiss AG | Results Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara® alvotech.com ↗
The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint. |
| 2022-05-16 | Alvotech Swiss AG | Results Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for AVT04, a Proposed Biosimilar to Stelara® alvotech.com ↗
The study results demonstrated bioequivalence between AVT04 and the reference products. |
| 2022-04-18 | Amgen | Results AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB) amgen.com ↗
The study met the primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and STELARA. |
| 2022-02-18 | Janssen Research & Development, LLC | Results The Majority of Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study Achieved Clinical Remission and Corticosteroid-Free Remission Through 48 Weeks with TREMFYA® (guselkumab) jnj.com ↗
With STELARA® (ustekinumab), which was used as a reference arm, 58.7 percent of patients achieved clinical remission. |
| 2021-10-25 | Janssen Research & Development, LLC | Results New Analyses Suggest Favorable Results for STELARA® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis jnj.com ↗ |
| 2021-10-08 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA). |
| 2021-10-08 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis jnj.com ↗
Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis |
| 2021-10-04 | Janssen Research & Development, LLC | Results New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications jnj.com ↗
This analysis arms physicians with data to consider when treating older patients with STELARA given the safety profile observed across all approved indications. |
| 2021-10-04 | Janssen Research & Development, LLC | Results New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications jnj.com ↗
New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications |
| 2021-07-09 | Janssen Research & Development, LLC | Results STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial jnj.com ↗
55.2 percent of patients were in symptomatic remissionaat week 152. |
| 2021-07-09 | Janssen Research & Development, LLC | Results STELARA® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Rates in Adults with Moderately to Severely Active Ulcerative Colitis at Nearly Three Years in Long-Term Extension of Phase 3 Trial jnj.com ↗
The data demonstrated the majority (55.2 percent) of adult patients with moderately to severely active ulcerative colitis (UC) who initially responded to treatment with STELARA sustained symptomatic remissiona rates at nearly three years (week 152). |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease jnj.com ↗
SEAVUE has generated data that confirm STELARA as an important option for people living with moderately to severely active Crohn’s disease who are new to biologic therapy. |
| 2021-05-23 | Janssen Research & Development, LLC | Results Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease jnj.com ↗
Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease |
| 2020-10-12 | Janssen Research & Development, LLC | Results STELARA® (ustekinumab) Five-Year Results Presented from Long-term Extension Study of Clinical Response and Remission in Patients with Moderate to Severe Crohn’s Disease jnj.com ↗
Results from the IM-UNITI study showed that patients were able to maintain response with STELARA treatment through five years. |
| 2020-07-30 | Janssen Research & Development, LLC | Regulatory U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis jnj.com ↗ |
| 2020-06-26 | Janssen Research & Development, LLC | Results Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA®(ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE. |
| 2020-06-26 | Janssen Research & Development, LLC | Results Janssen Announces Discontinuation of Phase 3 LOTUS Study Evaluating Ustekinumab in Systemic Lupus Erythematosus jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today its decision to discontinue the Phase 3 LOTUS study of STELARA® (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE. |
| 2020-01-23 | Janssen Research & Development, LLC | Regulatory The European Commission Approves Expanded Use Of JANSSEN’S STELARA® (USTEKINUMAB) For The Treatment Of Paediatric Patients With Moderate To Severe Plaque Psoriasis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has approved the expanded use of STELARA® (ustekinumab) for the treatment of paediatric patients (ages 6–11) with moderate to severe plaque psoriasis. |
| 2019-10-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA®(ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. |
| 2019-10-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. |
| 2019-10-07 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis jnj.com ↗
Janssen Submits Application to U.S. FDA Seeking Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis |
| 2019-09-04 | Janssen Research & Development, LLC | Regulatory European Commission Approves Expanded Use of Janssen’s STELARA® (ustekinumab) for the Treatment of Moderately to Severely Active Ulcerative Colitis in the European Union jnj.com ↗
European Commission Approves Expanded Use of Janssen’s STELARA® (ustekinumab) for the Treatment of Moderately to Severely Active Ulcerative Colitis in the European Union |
| 2019-07-26 | Janssen Research & Development, LLC | Regulatory Janssen Receives CHMP Positive Opinion for STELARA® (USTEKINUMAB) Recommending Approval for the Treatment of Moderately to Severely Active Ulcerative Colitis in the EU jnj.com ↗
JANSSEN RECEIVES CHMP POSITIVE OPINION FOR STELARA® (USTEKINUMAB) RECOMMENDING APPROVAL FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN THE EU |
| 2019-03-05 | Novartis Pharmaceuticals | Results Novartis Cosentyx® shows superior improvements in psoriasis patients' quality of life versus Janssen's IL-23 Stelara®* novartis.com ↗
New CLARITY data show over two-thirds of Cosentyx treated patients with moderate to severe psoriasis reported no impact of skin disease on their QoL up to Week 16 compared to Stelara ® * (ustekinumab) treated patients (68.4% versus 55.9%, respectively)[1]. |
| 2019-01-07 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to European Medicines Agency Seeking Approval of STELARA® (USTEKINUMAB) for Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis jnj.com ↗ |
| 2018-12-20 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of STELARA® (USTEKINUMAB) for Treatment of Moderately to Severely Active Ulcerative Colitis jnj.com ↗ |
| 2018-10-09 | Janssen Research & Development, LLC | Results NEW PHASE 3 DATA SHOW SINGLE DOSE OF STELARA® (USTEKINUMAB) INDUCES CLINICAL REMISSION AND RESPONSE IN ADULTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS jnj.com ↗ |
| 2018-09-13 | AbbVie | Results AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis abbvie.com ↗
At week 16, significantly more risankizumab-treated patients reported a psoriasis symptom scale (PSS) score of 0, indicating they were symptom-free based on a score assessing pain, redness and itchiness, compared with STELARA ® (ustekinumab) and placebo in ultIMMa-1 and ultIMMa-2. |
| 2018-02-17 | AbbVie | Results AbbVie Presents New Positive Late-Breaking Data from Two Phase 3 Psoriasis Trials of Risankizumab at the 2018 American Academy of Dermatology Annual Meeting abbvie.com ↗
In today's presentation, additional ranked secondary endpoints showed significantly higher rates of skin clearance at week 16 and at one year of treatment, compared with ustekinumab, as measured by static Physician Global Assessment (sPGA 0). |
| 2018-01-16 | Novartis Pharmaceuticals | Results Novartis new data reinforces superiority of Cosentyx® versus Stelara®* in achieving skin clearance for psoriasis patients novartis.com ↗
Results from CLARITY study show Cosentyx ® (secukinumab) was significantly more effective than Stelara ®* (ustekinumab) in delivering clear and almost clear skin at 12 weeks and at 16 weeks[1] |
| 2017-10-26 | AbbVie | Results Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies abbvie.com ↗
today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque psoriasis. |
| 2017-10-13 | Janssen Research & Development, LLC | Regulatory JANSSEN ANNOUNCES U.S. FDA APPROVAL OF STELARA® (USTEKINUMAB) FOR THE TREATMENT OF ADOLESCENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS jnj.com ↗
Approval of STELARA® for adolescents 12 years or older provides an important new treatment option for adolescent plaque psoriasis patients |
| 2017-03-04 | Eli Lilly and Company | Results New Head-to-Head Data Shows Significantly Higher Response Rates for Lilly's Taltz® (ixekizumab) Compared to Stelara® (ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis lilly.com ↗ |
| 2017-02-17 | Janssen Research & Development, LLC | Results NEW DATA SHOWS STELARA® (USTEKINUMAB) MAINTAINED CLINICAL RESPONSE AND REMISSION AFTER TWO YEARS OF TREATMENT IN ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE jnj.com ↗
NEW DATA SHOWS STELARA® (USTEKINUMAB) MAINTAINED CLINICAL RESPONSE AND REMISSION AFTER TWO YEARS OF TREATMENT IN ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE |
| 2016-10-01 | Novartis Pharmaceuticals | Results Novartis late-breaking data show Cosentyx delivers high and long-lasting skin clearance over 4 years for psoriasis patients novartis.com ↗
Newly published data also show Cosentyx delivers superior, long-lasting skin clearance versus Stelara ®** (ustekinumab) for up to 1 year in patients with moderate-to-severe psoriasis: 76% for Cosentyx vs. 61% for Stelara (P<0.0001) at 52 weeks[2]. |
| 2016-09-16 | Janssen Research & Development, LLC | Regulatory Janssen Receives CHMP Positive Opinion for STELARA® (ustekinumab) Recommending Approval for the Treatment of Moderately to Severely Active Crohn's Disease in the European Union jnj.com ↗
Janssen Receives CHMP Positive Opinion for STELARA® (ustekinumab) Recommending Approval for the Treatment of Moderately to Severely Active Crohn's Disease in the European Union |
| 2016-05-24 | Janssen Research & Development, LLC | Results New Phase 3 Study Findings Show STELARA® Maintained Clinical Remission After One Year Of Treatment In Patients With Moderate To Severe Crohn's Disease jnj.com ↗ |
| 2016-03-05 | Novartis Pharmaceuticals | Results Novartis' Cosentyx superior to Stelara in delivering long-lasting skin clearance (PASI 90) for psoriasis patients at 52 weeks novartis.com ↗
Novartis announced today new late-breaking data from the head-to-head CLEAR study, demonstrating that Cosentyx (secukinumab) remains superior to Stelara (ustekinumab) in achieving sustained skin clearance (PASI 90 response) at 52 weeks for adults living with moderate-to-severe psoriasis. |
| 2015-11-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits Applications Seeking Approval of Stelara® in United States and European Union for Crohn's Disease jnj.com ↗
Janssen Submits Applications Seeking Approval of Stelara® in United States and European Union for Crohn's Disease |
| 2015-10-19 | Janssen Research & Development, LLC | Results Phase 3 Data Show STELARA® Induced Clinical Response And Remission In The Treatment Of Patients With Moderate To Severe Crohn's Disease jnj.com ↗ |
| 2015-10-08 | Boehringer Ingelheim | Results Boehringer Ingelheim's investigational biologic cleared skin better, faster and for longer than ustekinumab in phase II psoriasis study prnewswire.com ↗
New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim's investigational biologic compound BI 655066*, over ustekinumab. |
| 2015-06-29 | Janssen Research & Development, LLC | Regulatory STELARA® Receives European Commission Approval for Treatment of Adolescents With Moderate-to-Severe Psoriasis in Europe jnj.com ↗
Janssen-Cilag International NV ("Janssen") announced today that the European Commission (EC) has approved STELARA® (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. |
| 2015-05-22 | Janssen Research & Development, LLC | Regulatory STELARA® Receives CHMP Positive Opinion For Treatment Of Adolescents With Moderate To Severe Psoriasis In Europe jnj.com ↗ |
| 2015-03-20 | Boehringer Ingelheim | Results Boehringer Ingelheim's Investigational Biologic Cleared Skin Better than Ustekinumab in Head-to-Head Phase II Psoriasis Study prnewswire.com ↗
Nearly double the percentage of patients with moderate-to-severe plaque psoriasis achieved clear or almost clear skin (described as PASI 90 ) after 12 weeks of treatment with BI 655066 compared to ustekinumab (77.1% versus 40% of patients). |
| 2015-03-20 | Novartis Pharmaceuticals | Results New Novartis data shows Cosentyx(TM) is significantly superior to Stelara® and clears skin (PASI 90) in nearly 80% of psoriasis patients novartis.com ↗
Novartis announced today results from the CLEAR study demonstrating that Cosentyx(TM) (secukinumab) is significantly superior to Stelara ® * (ustekinumab), a widely used biologic, in achieving clear or almost clear skin for psoriasis patients[1]. |
| 2015-03-13 | Novartis Pharmaceuticals | Results Novartis to present new late-breaking CosentyxTM data at AAD 2015 showing significant patient benefit in achieving clear skin novartis.com ↗
New data from the CLEAR study will include results that demonstrate Cosentyx is superior to Stelara ® * (ustekinumab) in clearing skin (PASI 90 and PASI 100) at Week 16[1]. |
| 2014-11-18 | AstraZeneca | Results AstraZeneca strategy on track to deliver sustainable growth and value through innovation astrazeneca.com ↗
Brodalumab, being developed in partnership with Amgen, showed superiority to Stelara (ustekinumab) in achieving total skin clearance (PASI 100) and met co-primary end-points against placebo. |
| 2014-11-11 | AstraZeneca | Results Amgen and AstraZeneca announce positive results from second pivotal Phase III study of Brodalumab in patients with moderate-to-severe plaque psoriasis astrazeneca.com ↗
Results showed that 36.7 percent of patients in the brodalumab 210 mg group, 27 percent of patients in the brodalumab 140 mg group, 18.5 percent of patients in the Stelara group and 0.3 percent of patients in the placebo group achieved total clearance of skin disease (PASI 100). |
| 2014-10-10 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application Seeking Approval Of STELARA® In European Union For Pediatric Plaque Psoriasis jnj.com ↗
Janssen-Cilag International NV (Janssen) announced today that a Type II Variation has been filed with the European Medicines Agency seeking approval of STELARA® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. |
| 2014-10-09 | Janssen Research & Development, LLC | Results New Findings From The Psoriasis Longitudinal Assessment And Registry (PSOLAR) jnj.com ↗
This particular analysis of the PSOLAR registry showed higher treatment longevity and lower rates of discontinuation with ustekinumab compared with anti-TNF-alpha agents. |
| 2013-10-28 | Janssen Research & Development, LLC | Results NEW STELARA® DATA SHOW INHIBITION OF JOINT DESTRUCTION IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS jnj.com ↗
New findings from two integrated Phase 3 Janssen Research & Development, LLC (Janssen) - sponsored studies showed treatment with STELARA® (ustekinumab) resulted in significantly greater inhibition of structural damage in patients with active psoriatic arthritis compared with placebo. |
| 2013-09-23 | Janssen Research & Development, LLC | Regulatory Stelara® Receives European Commission Approval for Treatment of Active Psoriatic Arthritis jnj.com ↗
Janssen-Cilag International NV ("Janssen") announced today that the European Commission has approved the use of STELARA (ustekinumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non -biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. |
| 2013-09-23 | Janssen Research & Development, LLC | Regulatory STELARA® (Ustekinumab) Receives FDA Approval To Treat Active Psoriatic Arthritis jnj.com ↗
Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA ® (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis. |
| 2013-07-26 | Janssen Research & Development, LLC | Regulatory Stelara® Receives CHMP Positive Opinion for Treatment of Psoriatic Arthritis jnj.com ↗
Stelara® Receives CHMP Positive Opinion for Treatment of Psoriatic Arthritis |
All press releases naming this drug 196 releases
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| Show all 196 releases opens the full record — a long page | ||
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 163 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ustekinumab | “BACKGROUND: This study assessed pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a candidate biosimilar, compared with reference product (RP) ustekinumab...” PMID 37212315 ↗ May 2023146“AVT04 is being developed to be a biosimilar with the European Union (EU)-licensed drug Stelara® (hereafter referred to as Stelara) ustekinumab” NCT04930042 ↗ “Ustekinumab: 260 mg (body weight ≤55kg), 390 mg (55-85kg) or 520 mg (\>85kg) IV at day 0, 90 mg SC at week 8 and every eight weeks thereafter.” NCT05169593 ↗ “new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).” NCT04505410 ↗ “IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).” NCT06274554 ↗ “The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.” NCT00267956 ↗ “CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab).” NCT04428814 ↗ “A commercial formulation of ustekinumab for SC control (0.5mg)” NCT05890118 ↗ “FYB202 (Proposed ustekinumab biosimilar)” NCT04595409 ↗ “Stelara® (Ustekinumab)” NCT04967508 ↗ “Ustekinumab (Stelara)” NCT07149792 ↗ |
| Known as | CNTO1275 | “Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23...” PMID 40357993 ↗ May 20258“This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.” NCT01090427 ↗ “An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis” NCT00723528 ↗ “Ustekinumab (CNTO 1275) is a monoclonal antibody directed against interleukins -12 and -23.” NCT00307437 ↗ “treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not” NCT00771667 ↗ “CNTO1275 (ustekinumab)” NCT00267956 ↗ |
| Known as | FYB202 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04595409 ↗ |
| Known as | SB17 | “Ustekinumab (SB17, EU sourced Stelara®, and US sourced Stelara®)” NCT04772274 ↗ |
| Known as | Stelara | “Ustekinumab (also known as STELARA) is an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for moderate to severe...” NCT01945086 ↗27“Our preliminary data demonstrates individual skin improvement (Responders) as well as lack of skin improvement (Non-Responders) in patients treated with monoclonal antibody...” NCT05270733 ↗ “This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety,...” NCT01081704 ↗ “Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab...” NCT01369342 ↗ “BACKGROUND: This study assessed pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a candidate biosimilar, compared with reference product (RP) ustekinumab...” PMID 37212315 ↗ May 2023 “A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis” NCT01645280 ↗ “A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)” NCT01276847 ↗ “In the single-phase part of the study, subjects receive a single dose of Stelara (ustekinumab) 270 mg subcutaneously on Day 0 study visit.” NCT02199496 ↗ “Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis” NCT01369329 ↗ “A Pilot Study to Investigate Ustekinumab (StelaraTM) for the Treatment of Active Sight-Threatening Uveitis” NCT01647152 ↗ “A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis” NCT01008995 ↗ |
| Known as | StelaraTM | “A Pilot Study to Investigate Ustekinumab (StelaraTM) for the Treatment of Active Sight-Threatening Uveitis” NCT01647152 ↗ |
| Known as | UST | “The investigators plan to include 20 patients, namely the first 10 patients who will be switched to ustekinumab (UST, n=10, only available for patients with CD) and the first...” NCT03629379 ↗9“To evaluate the efficacy and safety of ustekinumab (UST) in a multicentre, randomised, double-blind, placebo-controlled trial in adult Japanese patients with active...” PMID 37652554 ↗ Aug 2023 “OBJECTIVE: We investigated the impact of concomitant MTX on ustekinumab (UST) levels and antidrug antibody (ADA) formation in PsA and evaluated consequences in pharmacodynamics...” PMID 37079726 ↗ Dec 2023 “Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission...” NCT06912815 ↗ “This final long-term extension (LTE) analysis assessed the long-term efficacy and safety of ustekinumab (UST) in the Asian patient subpopulation of the UNITI/IM-UNITI study.” PMID 42427284 ↗ Jul 2026 “Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg) followed by UST SubCutaneous (SC) 90mg every 8 weeks.” NCT04496063 ↗ “Biologic therapies, such as vedolizumab (VDZ) and ustekinumab (UST), offer effective treatment options for inflammatory bowel disease.” PMID 41453773 ↗ Dec 2025 “ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD)” NCT05861167 ↗ “Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.” PMID 32415575 ↗ May 2020 “patients with Crohn\"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST)” NCT07303686 ↗ |
| Known as | Ustekinumab (Stelara) | “Ustekinumab (Stelara)” NCT02204397 ↗ |
| Action | Inhibit | “CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).” NCT00207727 ↗ |
| Modality | Monoclonal antibody | “Human Monoclonal Antibody to IL-12p40(CNTO1275)” NCT00207727 ↗ |
| Route | Subcutaneous | “Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo” NCT00207727 ↗ |
| Target | IL12B | “Anti-(Human Interleukin-12 Subunit beta (IL-12B, CLMF p40, NKSF2))” NCT04572815 ↗ |