Eksunbi

Withdrawn

This medicine's authorisation has been withdrawn

ustekinumab

Overview

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.

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.

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.

Eksunbi : EPAR - Medicine overview

Reference Number: EMA/388540/2024

Eksunbi : EPAR - Risk management plan

Product information

Eksunbi : EPAR - Product information

Eksunbi : EPAR - All authorised presentations

Product details

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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Crohn’s Disease
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.

Ulcerative colitis
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).

Plaque psoriasis
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).

Paediatric plaque psoriasis
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).

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).

Authorisation details

• EMA product number:
  EMEA/H/C/006448
• 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:
  Samsung Bioepis NL B.V.

  Olof Palmestraat 10; 2616 LR Delft; The Netherlands

• Opinion adopted:
  25/07/2024
• Marketing authorisation issued:
  12/09/2024
• Withdrawal of marketing authorisation:
  19/08/2025
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Eksunbi : EPAR - Procedural steps taken and scientific information after the authorisation

Eksunbi : EPAR - Procedural steps taken and scientific information after the authorisation (archive)

Initial marketing authorisation documents

Eksunbi : EPAR - Public assessment report

Adopted Reference Number: EMA/371773/2024

CHMP summary of positive opinion for Eksunbi

Adopted Reference Number: EMA/CHMP/322195/2024