Qoyvolma

Opinion

EMA has issued an opinion on this medicine

ustekinumab

Overview

On 27 March 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 Qoyvolma, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, Crohn’s disease or ulcerative colitis.

The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.

Qoyvolma will be available as a 45 or 90 mg solution for injection in pre-filled syringes, and a 130 mg concentrate for solution for infusion. The active substance of Qoyvolma 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 (IL) 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 psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Qoyvolma 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 Qoyvolma has comparable quality, safety and efficacy to Stelara (ustekinumab).

The full indication is:

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) (see section 5.1).

CHMP summary of positive opinion for Qoyvolma

AdoptedReference Number: EMA/89444/2025

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
• 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 applicant:
  Celltrion Healthcare Hungary Kft.
• Opinion adopted:
  27/03/2025
• Opinion status:
  Positive