Fymskina | European Medicines Agency (EMA)

March 3, 2025

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Overview

Fymskina is a medicine used to treat:

moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children above the age of 6 years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light;
active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Fymskina may be used alone or combined with methotrexate (a DMARD);
moderately to severely active Crohn’s disease (a disease-causing inflammation of the gut) in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments;
moderately to severely active ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) in adults whose condition has not improved enough with other treatments for ulcerative colitis or who cannot receive such treatments.

Fymskina contains the active substance ustekinumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Fymskina is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU.

Fymskina can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Fymskina is used for.

In plaque psoriasis and psoriatic arthritis, Fymskina is injected under the skin. The first injection is followed by a further injection 4 weeks later, and then an injection every 12 weeks.

In Crohn’s disease and ulcerative colitis, treatment is started with Fymskina infusion (drip) into a vein over at least 1 hour. Eight weeks after the first infusion, Fymskina is injected under the skin. Patients then continue with Fymskina injected under the skin every 8 or 12 weeks depending on how well the treatment is working.

Patients or their caregivers may inject Fymskina under the skin once they have been trained, if their doctor thinks that this is appropriate. For more information about using Fymskina, see the package leaflet or contact your doctor or pharmacist.

The active substance in Fymskina, ustekinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target in the body. Ustekinumab attaches to 2 messenger molecules in the immune system called interleukin 12 and interleukin 23. Both are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.

Laboratory studies comparing Fymskina with Stelara have shown that the active substance in Fymskina is highly similar to that in Stelara in terms of structure, purity and biological activity. Studies have also shown that giving Fymskina produces similar levels of the active substance in the body to giving Stelara.

In addition, a study of 392 patients with moderate to severe plaque psoriasis showed that Fymskina was as effective as Stelara in improving symptoms. The improvement in symptoms scores after 12 weeks was similar with both medicines.

Because Fymskina is a biosimilar medicine, the studies on effectiveness of ustekinumab carried out with Stelara do not all need to be repeated for Fymskina.

The safety of Fymskina has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Stelara.

For the complete list of side effects and restrictions of Fymskina, see the package leaflet.

The most common side effects with ustekinumab (seen in more than 1 in 20) include headache and nasopharyngitis (inflammation of the nose and throat). The most serious side effect reported with ustekinumab include serious hypersensitivity (allergic reaction).

Fymskina must not be used in patients who have an active infection that the doctor considers important.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fymskina has a highly similar structure, purity and biological activity to Stelara and is distributed in the body in the same way. In addition, a study in plaque psoriasis has shown that Fymskina and Stelara are equivalent in terms of safety and effectiveness in this condition.

All these data were considered sufficient to conclude that Fymskina will have the same effects as Stelara in its authorised uses. Therefore, the Agency’s view was that, as for Stelara, the benefits of Fymskina outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fymskina have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Fymskina are continuously monitored. Suspected side effects reported with Fymskina are carefully evaluated and any necessary action taken to protect patients.

Fymskina received a marketing authorisation valid throughout the EU on 25 September 2024.

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First published: 07/10/2024

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Product information

English (EN)
(963 KB – PDF)

First published: 07/10/2024Last updated: 03/03/2025

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Latest procedure affecting product information:
VR/0000248050

03/03/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(24.5 KB – PDF)

First published: 07/10/2024

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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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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.

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).

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.

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.

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Overview

How is Fymskina used?

How does Fymskina work?

What benefits of Fymskina have been shown in studies?

What are the risks associated with Fymskina?

Why is Fymskina authorised in the EU?

What measures are being taken to ensure the safe and effective use of Fymskina?

Other information about Fymskina

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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