Pyzchiva

Opinion

EMA has issued an opinion on this medicine

ustekinumab

Overview

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pyzchiva, intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults. The applicant for this medicinal product is Samsung Bioepis NL B.V.

Pyzchiva will be available as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion. The active substance of Pyzchiva is ustekinumab, an immunosuppressant interleukin inhibitor (ATC code: L04AC05). Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the shared p40 protein subunit of interleukin (IL)-12 and IL-23, thereby preventing them from binding to the IL‑12Rβ1 receptor protein expressed on the surface of immune cells. By doing so, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.

Pyzchiva 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 Pyzchiva has comparable quality, safety and efficacy to Stelara. More information on biosimilar medicines can be found here.

The full indication is:

Plaque psoriasis

Pyzchiva 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

Pyzchiva 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)

Pyzchiva, 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

Pyzchiva 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

Pyzchiva 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).

Pyzchiva should be prescribed by physicians experienced in the treatment of the conditions for which Pyzchiva is indicated.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Pyzchiva

AdoptedReference Number: EMA/56536/2024

Product details

• Name of medicine:
  Pyzchiva
• Active substance:
  Ustekinumab
• International non-proprietary name (INN) or common name:
  ustekinumab
• Therapeutic area (MeSH):
  • Crohn Disease
  • Colitis, Ulcerative
  • Arthritis, Psoriatic
• Anatomical therapeutic chemical (ATC) code:
  L04AC05
• EMA product number:
  EMEA/H/C/006183
• 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:
  Samsung Bioepis NL B.V.
• Opinion adopted:
  22/02/2024
• Opinion status:
  Positive