o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/786638/2015

EMEA/H/C/004007

EPAR summary for the public

Benepali

etanercept

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 anti-inflammatory medicine. It is used in adults for the treatment of the following

diseases:

•    moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints). 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;

•    psoriatic arthritis (inflammation of the joints which occurs in some patients with psoriasis) 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. Benepali is used in patients who have not responded to or cannot receive other treatments for this disease.

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Benepali contains the active substance etanercept and is a 'biosimilar medicine'. This means that Benepali is 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 question-and-answer document here.

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 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, as Benepali does not have low-dose formulations.

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?

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 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 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.

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 been shown to have a comparable quality,

Benepali

EMA/786638/2015    Page 2/3

safety and effectiveness to Enbrel. Therefore, the CHMP's view was that, as for Enbrel, the benefit outweighs the identified risk. The Committee recommended that Benepali be given marketing authorisation.

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

A risk management plan has been developed to ensure that Benepali is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Benepali, including the appropriate precautions to be followed by healthcare professionals and patients.

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. 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.

Further information can be found in the summary of the risk management plan.

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 01-2016.

Benepali

EMA/786638/2015