Usgena (ustekinumab)
- Region
- 🇪🇺 EU
- Active substance
- ustekinumab
- Company
- Stada Arzneimittel AG
- Status
- Authorised
- Therapeutic area
- Crohn Disease; Psoriasis; Arthritis, Psoriatic; Colitis, Ulcerative
- CHMP opinion
- Thu 18 Sep 2025
- EU approval
- Mon 17 Nov 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006667
- ATC
- L04AC05
- Official record
- www.ema.europa.eu
Indication
Crohn’s Disease Usgena 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. Ulcerative colitis Usgena 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. Plaque psoriasis Usgena 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) (see section 5.1). Paediatric plaque psoriasis Usgena 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 (see section 5.1). Psoriatic arthritis (PsA) Usgena, 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 (see section 5.1).
Regulatory milestones
Usgena (ustekinumab) approved in the EU
Marketing authorisation to Stada Arzneimittel AG; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Wezenla Authorised · Amgen Technology (Ireland) UC
- 🇪🇺 Otulfi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Pyzchiva Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Imuldosa Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Stelara Authorised · Janssen-Cilag International NV
- 🇪🇺 Fymskina Authorised · Formycon AG
- 🇪🇺 Steqeyma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Usymro Authorised · Gedeon Richter Plc.
- 🇪🇺 Uzpruvo Authorised · Stada Arzneimittel AG
- 🇪🇺 Usrenty Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 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.