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.
What is Benepali and what is it used for?
Benepali is an
•moderate to severe rheumatoid arthritis (an
•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
−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
•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;
•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
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 the
How is Benepali used?
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
Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have
How does Benepali work?
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.
What benefits of Benepali have been shown in studies?
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).
What are the risks associated with Benepali?
The most common side effects with Benepali are
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.
Why is Benepali approved?
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.
What measures are being taken to ensure the safe and effective use of Benepali?
The company that makes Benepali will provide educational material for doctors expected to prescribe the product (to teach patients how to use the
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.
Other information about Benepali
The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016.
The full EPAR and risk management plan summary for Benepali can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in