Eksunbi

RSS
Withdrawn

This medicine's authorisation has been withdrawn

ustekinumab
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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.

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Product information

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Latest procedure affecting product information:VR/0000267789
23/05/2025
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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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

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