Absimky

Withdrawn

This medicine's authorisation has been withdrawn

ustekinumab

Overview

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.

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.

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. 

Absimky : EPAR - Medicine overview

Reference Number: EMA/536423/2024

Absimky : EPAR - Risk Management Plan

Product information

Absimky : EPAR - Product information

Absimky : EPAR - All authorised presentations

Product details

• Name of medicine:
  Absimky
• Active substance:
  ustekinumab
• International non-proprietary name (INN) or common name:
  ustekinumab
• Therapeutic area (MeSH):
  • Crohn Disease
  • Colitis, Ulcerative
• Anatomical therapeutic chemical (ATC) code:
  L04AC05

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Plaque psoriasis

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).

Paediatric plaque psoriasis

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.

Psoriatic arthritis (PsA)

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.

Crohn’s Disease

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.

Ulcerative colitis

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.

Authorisation details

• EMA product number:
  EMEA/H/C/006585
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  17/10/2024
• Marketing authorisation issued:
  12/12/2024
• Withdrawal of marketing authorisation:
  15/12/2025
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Absimky : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Absimky : EPAR - Public assessment report

Adopted Reference Number: EMA/511029/2024

CHMP summary of positive opinion for Absimky

Adopted Reference Number: EMA/CHMP/448121/2024