Eksunbi (ustekinumab)
- Region
- 🇪🇺 EU
- Active substance
- ustekinumab
- Company
- Samsung Bioepis NL B.V.
- Status
- Withdrawn
- Therapeutic area
- Crohn Disease; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 12 Sep 2024
- Designations
- Biosimilar
- Application
- EMEA/H/C/006448
- ATC
- L04AC05
- Official record
- www.ema.europa.eu
Indication
Crohn’s DiseaseEksunbi 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 colitisEksunbi 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 or have medical contraindications to such therapies (see section 5.1).Plaque psoriasisEksunbi 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 psoriasisEksunbi 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)Eksunbi, 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
No milestones recorded in the last year.
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
- 🇪🇺 Usgena Authorised · Stada Arzneimittel AG
- 🇪🇺 Yesintek Authorised · Biosimilar Collaborations Ireland Limited
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