Overview

On 25 July 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 Fymskina, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn’s disease.

The applicant for this medicinal product is Formycon AG.

Fymskina will be available as 45 or 90 mg solution for injection in pre-filled syringe and 130 mg concentrate for solution for infusion. The active substance of Fymskina 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, ulcerative colitis and Crohn’s disease.

Fymskina 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 Fymskina has comparable quality, safety and efficacy to Stelara (ustekinumab). More information on biosimilar medicines can be found Biosimilars in the EU information guide.

The full indication is:

Plaque psoriasis

Fymskina 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

Fymskina is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older and who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).

Psoriatic arthritis (PsA)

Fymskina, 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

Fymskina 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

Fymskina 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).

Treatment with Fymskina 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 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 Fymskina

AdoptedReference Number: EMA/CHMP/294338/2024

English (EN) (153.54 KB - PDF)

First published:
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Product details

Name of medicine
Fymskina
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
EMA product number
EMEA/H/C/005805

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
Formycon AG
Opinion adopted
25/07/2024
Opinion status
Positive
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