<p>On 19 August 2025, the European Commission withdrew the marketing authorisation for Eksunbi (ustekinumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Samsung Bioepis NL B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons.</p><p>Eksunbi was granted marketing authorisation in the EU on 12 September 2024 for treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis. The product had not been marketed in the EU.</p><p>Eksunbi was a duplicate application to Pyzchiva which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Pyzchiva.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Crohn’s Disease<br>Eksunbi 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.<br><br>Ulcerative colitis<br>Eksunbi 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).<br><br>Plaque psoriasis<br>Eksunbi 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).<br><br>Paediatric plaque psoriasis<br>Eksunbi 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).<br><br>Psoriatic arthritis (PsA)<br>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).</p></div>
Therapeutic Area (MeSH)
ATC Code
L04AC05
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ustekinumab | N/A | ustekinumab |
EMA Name
Eksunbi
Medicine Name
Eksunbi
Aliases
N/ANo risk management plan link.
