Erelzi

etanercept

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This is a summary of the European public assessment report (EPAR) for Erelzi. 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 Erelzi.

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

What is Erelzi and what is it used for?

Erelzi is an anti-inflammatory medicine for treating the following diseases:

  • rheumatoid arthritis (a disease causing inflammation of the joints) in adults, used with another medicine, methotrexate, or alone;
  • certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints, with first appearance in childhood or adolescence);
  • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children;
  • psoriatic arthritis (psoriasis with inflammation of the joints) in adults and adolescents;
  • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults;
  • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.

Erelzi is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough or cannot be used. For detailed information on the use of Erelzi in all conditions, see the summary of product characteristics (also part of the EPAR).

Erelzi contains the active substance etanercept and is a ‘biosimilar medicine’. This means that Erelzi 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 Erelzi is Enbrel.

How is Erelzi used?

Erelzi is available as prefilled syringes and pens containing a solution for injection. The injection is given under the skin and the patient or their carer can give the injection if they have been trained appropriately. In adults, the usual recommended dose is 25 mg twice a week or 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. In children, the dose will depend on body weight. Erelzi is not for use in children who need doses other than 25 or 50 mg (e.g. those weighing less than 62.5 kg), because it is only available in these doses; an alternative product should be used in such children. For more information, see the package leaflet.

The medicine can only be obtained with a prescription. Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Erelzi is used for.

How does Erelzi work?

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

What benefits of Erelzi have been shown in studies?

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

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

Erelzi was also shown to be as effective as Enbrel in one main study involving 531 adults with plaque psoriasis. Over 70% of those given Erelzi (186 of 264 patients) and roughly 72% of those given Enbrel (191 of 267) had at least 75% reduction in their symptom score after 12 weeks of treatment, which was the main measure of effectiveness.

What are the risks associated with Erelzi?

The most common side effects with etanercept (seen in more than 1 patient in 10) 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 Erelzi treatment. For the full list of all side effects reported with Erelzi, see the package leaflet.

Erelzi 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 active infections. For the full list of restrictions, see the package leaflet.

Why is Erelzi approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Erelzi 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 Erelzi be given marketing authorisation.

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

The company that markets Erelzi will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor. The educational materials also include a reminder that Erelzi is not for use in children and adolescents who weigh less than 62.5 kg.

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

Other information about Erelzi

The European Commission granted a marketing authorisation valid throughout the European Union for Erelzi on 23 June 2017.

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

Name Language First published Last updated
Erelzi : EPAR - Summary for the public BG = bălgarski 2017-06-29  
Erelzi : EPAR - Summary for the public ES = español 2017-06-29  
Erelzi : EPAR - Summary for the public CS = čeština 2017-06-29  
Erelzi : EPAR - Summary for the public DA = dansk 2017-06-29  
Erelzi : EPAR - Summary for the public DE = Deutsch 2017-06-29  
Erelzi : EPAR - Summary for the public ET = eesti keel 2017-06-29  
Erelzi : EPAR - Summary for the public EL = elliniká 2017-06-29  
Erelzi : EPAR - Summary for the public EN = English 2017-06-29  
Erelzi : EPAR - Summary for the public FR = français 2017-06-29  
Erelzi : EPAR - Summary for the public IT = italiano 2017-06-29  
Erelzi : EPAR - Summary for the public LV = latviešu valoda 2017-06-29  
Erelzi : EPAR - Summary for the public LT = lietuvių kalba 2017-06-29  
Erelzi : EPAR - Summary for the public HU = magyar 2017-06-29  
Erelzi : EPAR - Summary for the public MT = Malti 2017-06-29  
Erelzi : EPAR - Summary for the public NL = Nederlands 2017-06-29  
Erelzi : EPAR - Summary for the public PL = polski 2017-06-29  
Erelzi : EPAR - Summary for the public PT = português 2017-06-29  
Erelzi : EPAR - Summary for the public RO = română 2017-06-29  
Erelzi : EPAR - Summary for the public SK = slovenčina 2017-06-29  
Erelzi : EPAR - Summary for the public SL = slovenščina 2017-06-29  
Erelzi : EPAR - Summary for the public FI = suomi 2017-06-29  
Erelzi : EPAR - Summary for the public SV = svenska 2017-06-29  
Erelzi : EPAR - Summary for the public HR = Hrvatski 2017-06-29  

This EPAR was last updated on 29/09/2017 .

Authorisation details

Product details

Product details for Erelzi
NameErelzi
Agency product numberEMEA/H/C/004192
Active substance

etanercept

International non-proprietary name (INN) or common name

etanercept

Therapeutic area Spondylitis, AnkylosingArthritis, RheumatoidArthritis, PsoriaticPsoriasisArthritis, Juvenile Rheumatoid
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 Erelzi
Marketing-authorisation holder

Sandoz GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union23/06/2017

Contact address:

Sandoz GmbH
Biochemiestrasse 10 
6250 Kundl 
Austria

Product information

Product information

28/07/2017  Erelzi -EMEA/H/C/004192 -IB/001/G

Name Language First published Last updated
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-29

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
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29
Erelzi : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-29

Pharmacotherapeutic group

Immunosuppressant, tumor necrosis factor alpha (tnf-a) inhibitors

Therapeutic indication

Rheumatoid arthritis

Erelzi 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.

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

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

Etanercept, 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 (AS)

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 non‑steroidal 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Erelzi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-09-29  

Initial marketing-authorisation documents

Name Language First published Last updated
Erelzi : EPAR - Public assessment report HR = Hrvatski 2017-06-29  
CHMP summary of positive opinion for Erelzi HR = Hrvatski 2017-04-21  

Authorised

This medicine is approved for use in the European Union

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