Flixabi

infliximab

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

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

What is Flixabi and what is it used for?

Flixabi is an anti-inflammatory medicine. It is used in adults, usually when other medicines or treatments have failed or cannot be used, for the treatment of the following diseases:

  • rheumatoid arthritis (an immune-system disease causing inflammation of the joints). Flixabi is used with methotrexate (a medicine that acts on the immune system);
  • Crohn’s disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);
  • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
  • ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
  • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
  • psoriasis (a disease causing red, scaly patches on the skin).

Flixabi is also used in patients aged between 6 and 17 years with severe Crohn’s disease or ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.

For further information see the summary of product characteristics (also part of the EPAR).

Flixabi contains the active substance infliximab and is a ‘biosimilar medicine’. This means that Flixabi 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 Flixabi is Remicade.

How is Flixabi used?

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

Flixabi is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary. The dose is 5 mg per kilogram for the other diseases. How often the treatment is repeated depends on which disease is being treated, and on the patient’s response to the medicine.

Flixabi is given as an infusion lasting one or two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Flixabi or the infusion time may be slowed down. For further information, see the package leaflet.

How does Flixabi work?

The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity. TNF-alpha is involved in causing inflammation and is found at high levels in patients with the diseases that Flixabi is used to treat. By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases.

What benefits of Flixabi have been shown in studies?

Studies were carried out to show that Flixabi is comparable to Remicade, including a study to show that it produces similar levels of the active substance in the body to Remicade.

Flixabi was also compared with Remicade in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous 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 30 weeks of treatment. Results of this study showed that Flixabi was as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of those treated with Flixabi (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Remicade (163 out of 247).

What are the risks associated with Flixabi?

The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain. Some side effects, including infections, may be more common in children than in adults. For the full list of all side effects reported with Flixabi, see the package leaflet.

Flixabi must not be used in patients who are hypersensitive (allergic) to infliximab, mouse proteins or any of the other ingredients of Flixabi. Flixabi must also not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).

Why is Flixabi approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade. Therefore, the CHMP’s view was that, as for Remicade, the benefit outweighs the identified risk. The Committee recommended that Flixabi be given marketing authorisation.

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

A risk management plan has been developed to ensure that Flixabi 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 Flixabi, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Flixabi will provide an alert card for patients and educational material for prescribers, summarising the safety information about the medicine. In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn’s disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.

Other information about Flixabi

The European Commission granted a marketing authorisation valid throughout the European Union for Flixabi on 26 May 2016.

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

Name Language First published Last updated
Flixabi : EPAR - Summary for the public BG = bălgarski 2016-06-09  
Flixabi : EPAR - Summary for the public ES = español 2016-06-09  
Flixabi : EPAR - Summary for the public CS = čeština 2016-06-09  
Flixabi : EPAR - Summary for the public DA = dansk 2016-06-09  
Flixabi : EPAR - Summary for the public DE = Deutsch 2016-06-09  
Flixabi : EPAR - Summary for the public ET = eesti keel 2016-06-09  
Flixabi : EPAR - Summary for the public EL = elliniká 2016-06-09  
Flixabi : EPAR - Summary for the public EN = English 2016-06-09  
Flixabi : EPAR - Summary for the public FR = français 2016-06-09  
Flixabi : EPAR - Summary for the public IT = italiano 2016-06-09  
Flixabi : EPAR - Summary for the public LV = latviešu valoda 2016-06-09  
Flixabi : EPAR - Summary for the public LT = lietuvių kalba 2016-06-09  
Flixabi : EPAR - Summary for the public HU = magyar 2016-06-09  
Flixabi : EPAR - Summary for the public MT = Malti 2016-06-09  
Flixabi : EPAR - Summary for the public NL = Nederlands 2016-06-09  
Flixabi : EPAR - Summary for the public PL = polski 2016-06-09  
Flixabi : EPAR - Summary for the public PT = português 2016-06-09  
Flixabi : EPAR - Summary for the public RO = română 2016-06-09  
Flixabi : EPAR - Summary for the public SK = slovenčina 2016-06-09  
Flixabi : EPAR - Summary for the public SL = slovenščina 2016-06-09  
Flixabi : EPAR - Summary for the public FI = suomi 2016-06-09  
Flixabi : EPAR - Summary for the public SV = svenska 2016-06-09  
Flixabi : EPAR - Summary for the public HR = Hrvatski 2016-06-09  

This EPAR was last updated on 15/11/2016 .

Authorisation details

Product details

Product details for Flixabi
NameFlixabi
Agency product numberEMEA/H/C/004020
Active substance

infliximab

International non-proprietary name (INN) or common name

infliximab

Therapeutic area Spondylitis, AnkylosingArthritis, RheumatoidColitis, UlcerativeArthritis, PsoriaticCrohn DiseasePsoriasis
Anatomical therapeutic chemical (ATC) code L04AB02
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 Flixabi
Marketing-authorisation holder

Samsung Bioepis UK Limited (SBUK)

Revision2
Date of issue of marketing authorisation valid throughout the European Union26/05/2016

Contact address:

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

Product information

Product information

11/10/2016  Flixabi -EMEA/H/C/004020 -IB/0008

Name Language First published Last updated
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15
Flixabi : EPAR - Product Information HR = Hrvatski 2016-06-09 2016-11-15

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
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12
Flixabi : EPAR - All Authorised presentations HR = Hrvatski 2016-06-09 2016-07-12

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:

  • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
  • dult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1).

Adult Crohn’s disease

Flixabi is indicated for:

  • reatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
  • reatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

Paediatric Crohn’s disease

Flixabi is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.

Ulcerative colitis

Flixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Paediatric ulcerative colitis

Flixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

Ankylosing spondylitis

Flixabiis indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

Psoriatic arthritis

Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.

Flixabi should be administered:

  • in combination with methotrexate
  • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.

Infliximab 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 (see section 5.1).

Psoriasis

Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Flixabi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-07-12 2016-11-15

Initial marketing-authorisation documents

Name Language First published Last updated
Flixabi : EPAR - Public assessment report HR = Hrvatski 2016-06-09  
CHMP summary of opinion for Flixabi HR = Hrvatski 2016-04-01  

Authorised

This medicine is approved for use in the European Union

More information on Flixabi