Usrenty

Opinion

EMA has issued an opinion on this medicine

ustekinumab

Overview

On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Usrenty, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.

The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.

Usrenty will be available as a 45 mg solution for injection in vials or pre-filled syringes, a 90 mg solution for injection in pre-filled syringes and a 130 mg concentrate for solution for infusion. The active substance of Usrenty is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn’s disease.

Usrenty is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorised in the EU on 15 January 2009. Data show that Usrenty has comparable quality, safety and efficacy to product Stelara. 

Plaque psoriasis

Usrenty 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

Usrenty 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)

Usrenty, 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).

Crohn’s disease

Usrenty 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.

Treatment with Usrenty should be prescribed and supervised by physicians experienced in the diagnosis and treatment of the conditions for which it is indicated.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Usrenty

AdoptedReference Number: EMA/CHMP/241636/2025

Product details

• Name of medicine:
  Usrenty
• Active substance:
  ustekinumab
• International non-proprietary name (INN) or common name:
  ustekinumab
• Therapeutic area (MeSH):
  Crohn Disease
• Anatomical therapeutic chemical (ATC) code:
  L04AC05
• EMA product number:
  EMEA/H/C/006794
• 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 applicant:
  Biosimilar Collaborations Ireland Limited
• Opinion adopted:
  24/07/2025
• Opinion status:
  Positive