Otulfi (ustekinumab)
- Region
- 🇪🇺 EU
- Active substance
- ustekinumab
- Company
- Fresenius Kabi Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Crohn Disease; Colitis, Ulcerative
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Wed 25 Sep 2024
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006544
- ATC
- L04AC05
- Official record
- www.ema.europa.eu
Indication
Plaque psoriasisOtulfi is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasisOtulfi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA)Otulfi, alone or in combination with MTX, is indicated 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. Adult Crohn’s DiseaseOtulfi is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's DiseaseOtulfi is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Crohn’s DiseaseOtulfi is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Ulcerative colitis Otulfi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.