Usrenty (ustekinumab)
- Region
- 🇪🇺 EU
- Active substance
- ustekinumab
- Company
- Biosimilar Collaborations Ireland Limited
- Status
- Authorised
- Therapeutic area
- Crohn Disease
- CHMP opinion
- Thu 24 Jul 2025
- EU approval
- Wed 17 Sep 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006794
- ATC
- L04AC05
- Official record
- www.ema.europa.eu
Indication
Plaque psoriasis Usrenty 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 psoriasis Usrenty is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Usrenty, 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. Crohn’s Disease Usrenty 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Fymskina Authorised · Formycon AG
- 🇪🇺 Steqeyma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Usymro Authorised · Gedeon Richter Plc.
- 🇪🇺 Uzpruvo Authorised · Stada Arzneimittel AG
- 🇪🇺 Usgena Authorised · Stada Arzneimittel AG
- 🇪🇺 Yesintek Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Qoyvolma Withdrawn · Celltrion Healthcare Hungary Kft.
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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.