<p>On 15 December 2025, the European Commission withdrew the marketing authorisation for Absimky (ustekinumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Accord Healthcare S.L.U., which notified the European Commission of its decision not to market the product in the EU for commercial reasons.</p><p>Absimky was granted marketing authorisation in the EU on 12 December 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>Absimky was a duplicate application to Imuldosa, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Imuldosa. </p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Plaque psoriasis</p><p>ABSIMKY 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).</p><p>Paediatric plaque psoriasis</p><p>ABSIMKY 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.</p><p>Psoriatic arthritis (PsA)</p><p>ABSIMKY, 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 antirheumatic drug (DMARD) therapy has been inadequate.</p><p>Crohn’s Disease</p><p>Absimky 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.</p><p>Ulcerative colitis</p><p>Absimky 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.</p><p><u5:p></u5:p></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
Absimky
Medicine Name
Absimky
Aliases
N/ANo risk management plan link.
