Fubelv
Authorised
This medicine is authorised for use in the European Union
etanercept
MedicineHumanAuthorised
Finnish is available via eTranslation, the European Commission's machine translation service.
Translate to Finnish | Important information about machine translation
Overview
Fubelv is an anti-inflammatory medicine for treating the following immune system diseases:
- rheumatoid arthritis (a disease causing inflammation of the joints); it is used alone or with another medicine called methotrexate;
- certain forms of juvenile idiopathic arthritis (a childhood disease causing inflammation of the joints);
- plaque psoriasis (a disease causing red, scaly patches on the skin);
- psoriatic arthritis (psoriasis with inflammation of the joints);
- axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and non-radiographic axial spondyloarthritis which is when there are clear signs of inflammation but X-ray does not show disease.
Fubelv is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used. It is used in adults and, for some conditions, in children. For detailed information on the use of Fubelv in all conditions, see the package leaflet or contact your doctor or pharmacist.
Fubelv contains the active substance etanarcept and is a biological medicine. It is a ‘biosimilar medicine’; this means that Fubelv is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Fubelv is Enbrel. For more information on biosimilar medicines, see here.
Fubelv can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in diagnosing and treating the diseases it is used for.
Fubelv is given by injection under the skin. In adults, the medicine is injected once or twice a week. In children, it is injected every 3 to 4 days or once a week. Some children may require a dose that Fubelv does not provide; in such cases, another etanarcept medicine that offers an appropriate dose should be used.
Patients or their caregivers may inject Fubelv once they have been trained, if their doctor thinks that this is appropriate.
For more information about using Fubelv, see the package leaflet or contact your doctor or pharmacist.
The active substance in Fubelv, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor alpha (TNF alpha). TNF alpha is involved in causing inflammation and is found at high levels in people with the diseases that Fubelv is used to treat. By blocking TNF alpha, etanercept reduces inflammation and other symptoms of these diseases.
Laboratory studies comparing Fubelv with Enbrel have shown that the active substance in Fubelv is highly similar to that in Enbrel in terms of structure, purity and biological activity. Studies have also shown that giving Fubelv produces similar levels of the active substance in the body to those seen with Enbrel.
In addition, Fubelv was shown to be as effective as Enbrel in a main study involving 517 adults with moderate to severe rheumatoid arthritis who were being treated with methotrexate. The main measure of effectiveness was the number of patients with at least a 20% reduction in the number of tender and swollen joints, together with improvement in other symptoms of rheumatoid arthritis such as pain, signs of inflammation and the ability of the patient to carry out daily activities.
After about 6 months of treatment, Fubelv was found to be effective at reducing symptoms of rheumatoid arthritis in approximately 81% of patients, and Enbrel was effective in about 87% of patients.
Because Fubelv is a biosimilar medicine, the studies on the effectiveness of etanarcept carried out with Enbrel do not all need to be repeated for Fubelv.
Studies carried out with Fubelv are described in more detail in the medicine’s assessment report.
The safety of Fubelv has been evaluated and, based on all the studies carried out, the side effects of the medicine are considered to be comparable to those of Enbrel.
For the full list of side effects and restrictions of Fubelv, see the package leaflet.
The most common side effects with Fubelv (which may affect more than 1 in 10 people) include reactions at the injection site (such as bleeding, bruising, redness, itching, pain and swelling) and infections of the nose and throat, lungs, bladder and skin.
Fubelv must not be used in people who have or are at risk of sepsis (when bacteria and toxins circulate in the blood leading to organ damage), or in people who have an active infection.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fubelv has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way.
In addition, a study has shown that Fubelv and Enbrel are equivalent in terms of safety and effectiveness in rheumatoid arthritis.
All these data were considered sufficient to conclude that Fubelv will have the same effects as Enbrel in its authorised uses. Therefore, the Agency’s view was that, as for Enbrel, the benefits of Fubelv outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Fubelv will provide a card for patients that contains information on how to recognise serious side effects and when to see their doctor urgently.
This patient card will be made available by national competent authorities on their websites. A list of these national resources is available on the EMA website.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fubelv have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Fubelv are continuously monitored. Suspected side effects reported with Fubelv are carefully evaluated and any necessary action taken to protect patients.
Fubelv received a marketing authorisation valid throughout the EU on 23 April 2026.
Product information
Latest procedure affecting product information:VR/0000351211
11/06/2026
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).
Product details
- Name of medicine
- Fubelv
- International non-proprietary name (INN) or common name
- etanercept
- Therapeutic area (MeSH)
- Arthritis, Rheumatoid
- Arthritis, Juvenile
- Arthritis, Psoriatic
- Axial Spondyloarthritis
- Non-Radiographic Axial Spondyloarthritis
- Spondylitis, Ankylosing
- Psoriasis
- Anatomical therapeutic chemical (ATC) code
- L04AB01
Pharmacotherapeutic group
etanerceptTherapeutic indication
Rheumatoid arthritis
Fubelv in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Fubelv can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Fubelv is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Fubelv, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Axial spondyloarthritis
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non-radiographic axial spondyloarthritis
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).
Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
News on Fubelv
This page was last updated on