Overview

This is a summary of the European public assessment report (EPAR) for Benepali. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Benepali.

For practical information about using Benepali, patients should read the package leaflet or contact their doctor or pharmacist.

Benepali is an anti-inflammatory medicine. It is used for the treatment of the following diseases:

  • moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over). Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient. Benepali can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before;
  • certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups:
    • patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate;
    • adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate;
    • adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment;
  • psoriatic arthritis in adults who have not responded adequately to other treatments;
  • severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments;
  • severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray;
  • plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease. Benepali is used in patients who have not responded to or cannot receive other treatments for this disease.

Benepali contains the active substance etanercept and is a ‘biosimilar medicine’. This means that Benepali is highly similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Benepali is Enbrel.

For more information on biosimilar medicines, see related information.

Benepali treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Benepali is used to treat. The medicine can only be obtained with a prescription.

Benepali is available as pre-filled syringes or pens containing a solution for injecting under the skin. The usual recommended dose is 50 mg once a week. Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis. The patient or carer can give the injection after appropriate training. For more information, see the package leaflet.

Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations.

The active substance in Benepali, etanercept, is a protein designed to block the activity of a protein in the body called tumour necrosis factor (TNF). This protein is found at high levels in patients with the diseases that Benepali is used to treat. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.

Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity.

Because Benepali is a biosimilar medicine, all the studies on effectiveness and safety of etanercept carried out with Enbrel do not need to be repeated for Benepali. A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel.

Benepali was also compared with Enbrel in one main study involving 596 adult patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate. The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 24 weeks of treatment. Results of this study showed that Benepali is as effective as Enbrel at reducing symptoms of rheumatoid arthritis: 78% of patients given Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared with 80% of patients given Enbrel (188 out of 234).

The most common side effects with Benepali are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections). Patients developing a serious infection should stop Benepali treatment. For the full list of all side effects reported with Benepali, see the package leaflet.

Benepali must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections. For the full list of restrictions, see the package leaflet.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali 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 comparing Benepali to Enbrel in adults with rheumatoid arthritis showed that both medicines are similarly effective. Thus, all these data were considered sufficient to conclude that Benepali will behave in the same way in terms of effectiveness in adults as in children in Benepali’s approved indications. Therefore, the CHMP’s view was that, as for Enbrel, the benefits outweighs the identified risks. The Committee recommended that Benepali be given marketing authorisation.

The company that makes Benepali will provide educational material for doctors expected to prescribe the product (to teach patients how to use the pre-filled syringe/pen correctly). The educational materials also include a reminder that Benepali is not for use in children and adolescents who weigh less than 62.5 kg. Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor.

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

The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016.

For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Product information

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Latest procedure affecting product information: EMEA/H/C/PSUSA/00010795/202302

07/12/2023

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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).

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Product details

Name of medicine
Benepali
Active substance
etanercept
International non-proprietary name (INN) or common name
etanercept
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
  • Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AB01

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Benepali 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.

Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Benepali, 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.

Etanercept has not been studied in children aged less than 2 years.

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.

Authorisation details

EMA product number
EMEA/H/C/004007

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 holder
Samsung Bioepis NL B.V.

Olof Palmestraat 10
2616 LR Delft
The Netherlands

Opinion adopted
19/11/2015
Marketing authorisation issued
13/01/2016
Revision
23

Assessment history

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