Benepali

etanercept

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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.

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.

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, 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.

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

Name Language First published Last updated
Benepali : EPAR - Summary for the public BG = bălgarski 28/01/2016  
Benepali : EPAR - Summary for the public ES = español 28/01/2016  
Benepali : EPAR - Summary for the public CS = čeština 28/01/2016  
Benepali : EPAR - Summary for the public DA = dansk 28/01/2016  
Benepali : EPAR - Summary for the public DE = Deutsch 28/01/2016  
Benepali : EPAR - Summary for the public ET = eesti keel 28/01/2016  
Benepali : EPAR - Summary for the public EL = elliniká 28/01/2016  
Benepali : EPAR - Summary for the public EN = English 28/01/2016  
Benepali : EPAR - Summary for the public FR = français 28/01/2016  
Benepali : EPAR - Summary for the public IT = italiano 28/01/2016  
Benepali : EPAR - Summary for the public LV = latviešu valoda 28/01/2016  
Benepali : EPAR - Summary for the public LT = lietuvių kalba 28/01/2016  
Benepali : EPAR - Summary for the public HU = magyar 28/01/2016  
Benepali : EPAR - Summary for the public MT = Malti 28/01/2016  
Benepali : EPAR - Summary for the public NL = Nederlands 28/01/2016  
Benepali : EPAR - Summary for the public PL = polski 28/01/2016  
Benepali : EPAR - Summary for the public PT = português 28/01/2016  
Benepali : EPAR - Summary for the public RO = română 28/01/2016  
Benepali : EPAR - Summary for the public SK = slovenčina 28/01/2016  
Benepali : EPAR - Summary for the public SL = slovenščina 28/01/2016  
Benepali : EPAR - Summary for the public FI = suomi 28/01/2016  
Benepali : EPAR - Summary for the public SV = svenska 28/01/2016  
Benepali : EPAR - Summary for the public HR = Hrvatski 28/01/2016  
Name Language First published Last updated
Benepali : EPAR - Risk-management-plan summary (English only) 28/01/2016  

This EPAR was last updated on 08/08/2016 .

Authorisation details

Product details

Product details for Benepali
NameBenepali
Agency product numberEMEA/H/C/004007
Active substance

etanercept

International non-proprietary name (INN) or common name

etanercept

Therapeutic area Arthritis, RheumatoidArthritis, PsoriaticPsoriasis
Anatomical therapeutic chemical (ATC) code L04AB01
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Benepali
Marketing-authorisation holder

Samsung Bioepis UK Limited (SBUK)
Regus Building 
3000 Hillswood Drive 
Surrey 
Chertsey KT16 0RS
United Kingdom

Revision3
Date of issue of marketing authorisation valid throughout the European Union14/01/2016

Product information

Product information

28/06/2016  Benepali -EMEA/H/C/004007 -IB/0010

Name Language First published Last updated
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016
Benepali : EPAR - Product Information EN = English 28/01/2016 08/08/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016
Benepali : EPAR - All Authorised presentations EN = English 28/01/2016 16/03/2016

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.

Psoriatic arthritis

  • Treatment of active and progressive psoriatic arthritis in adults when the response to previous diseasemodifying 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).

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).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Benepali : EPAR - Procedural steps taken and scientific information after authorisation EN = English 16/03/2016 08/08/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Benepali : EPAR - Public assessment report EN = English 28/01/2016  
CHMP summary of positive opinion for Benepali EN = English 20/11/2015  

Authorised

This medicine is approved for use in the European Union

More information on Benepali