Qoyvolma

Withdrawn

This medicine's authorisation has been withdrawn

ustekinumab

Overview

On 12 June 2026 the European Commission withdrew the marketing authorisation for Qoyvolma (ustekinumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Celltrion Healthcare Hungary Kft., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Qoyvolma was granted marketing authorisation in the EU on 2 June 2025 for the treatment of adult and paediatric Crohn's disease, ulcerative colitis, plaque psoriasis including paediatric plaque psoriasis, and psoriatic arthritis. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since its initial authorisation in 2025.

Qoyvolma was a duplicate application to Steqeyma, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Steqeyma.

Qoyvolma : EPAR - Medicine overview

Qoyvolma : EPAR - Risk management plan

Product information

Qoyvolma : EPAR - Product information

Qoyvolma : EPAR - All authorised presentations

Product details

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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Adult Crohn’s Disease 
Qoyvolma 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. 
 
Paediatric Crohn's Disease  
Qoyvolma is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.  
 
Ulcerative colitis 
Qoyvolma 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. 

Plaque psoriasis 
Qoyvolma 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 
Qoyvolma 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) 
Qoyvolma, 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.

Authorisation details

• EMA product number:
  EMEA/H/C/006649
• 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:
  Celltrion Healthcare Hungary Kft.

  1062 Budapest; Váci út 1-3. WestEnd Office Building B torony; Hungary

• Opinion adopted:
  27/03/2025
• Marketing authorisation issued:
  02/06/2025
• Withdrawal of marketing authorisation:
  12/06/2026
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Qoyvolma : EPAR - Public assessment report

Adopted Reference Number: EMA/130000/2025

CHMP summary of positive opinion for Qoyvolma

Adopted Reference Number: EMA/89444/2025