Remsima

infliximab

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This is a summary of the European public assessment report (EPAR) for Remsima. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Remsima.

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

What is Remsima and what is it used for?

Remsima is an anti-inflammatory medicine that contains the active substance infliximab. It is usually used when other medicines or treatments have failed, in adults with the following diseases:

  • rheumatoid arthritis (an immune-system disease causing inflammation of the joints). Remsima is used with methotrexate (a medicine that acts on the immune system);
  • Crohn’s disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of 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).

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

See the summary of product characteristics (also part of the EPAR) for full details.

‘Remsima is a ‘biosimilar medicine'. This means that Remsima is similar to a biological medicine (the ‘reference medicine’) that is already authorised in the EU and that Remsima and the reference medicine contain the same active substance. The reference medicine for Remsima is Remicade.

How is Remsima used?

Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein. It can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Remsima can be used to treat.

Remsima 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.

Remsima 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 Remsima or the infusion time may be slowed down. For more information, see the package leaflet.

Patients who receive Remsima must be given a special alert card that summarises the safety information about the medicine.

How does Remsima work?

The active substance in Remsima, infliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor alpha (TNF-alpha). This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remsima is used to treat. By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.

Remsima is produced by a method known as ‘recombinant DNA technology’. The infliximab is made by cells that have received a gene (DNA), which makes them able to produce it.

What benefits of Remsima have been shown in studies?

Remsima was studied to show that it is comparable to the reference medicine, Remicade. Remsima was compared with Remicade in one main study involving 606 adults with rheumatoid arthritis. Patients received either Remsima or Remicade in addition to methotrexate for 30 weeks. The main measure of effectiveness was the change in symptoms. After 30 weeks of treatment Remsima was as effective as Remicade, with around 60% of patients responding to treatment with either medicine.

An additional study was also carried involving 250 patients with ankylosing spondylitis out to show that Remsima produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.

What are the risks associated with Remsima?

The most common side effects with Remsima (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 Remsima, see the package leaflet.

Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remsima. Remsima must 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 Remsima approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Remsima has been shown to have a comparable quality, safety and efficacy profile to Remicade. Therefore, the CHMP’s view was that, as for Remicade, the benefit outweighs the identified risks. The Committee recommended that Remsima be approved for use in the EU.

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

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

In addition, the company that markets Remsima will provide educational material to doctors who are expected to prescribe the medicine in adults and children, including information on the safety of the medicine and an alert card to be given to patients. The company will also carry out studies to confirm the long-term safety of the medicine.

Other information about Remsima

The European Commission granted a marketing authorisation valid throughout the EU for Remsima on 10 September 2013.

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

Name Language First published Last updated
Remsima : EPAR - Summary for the public BG = bălgarski 04/10/2013  
Remsima : EPAR - Summary for the public ES = español 04/10/2013  
Remsima : EPAR - Summary for the public CS = čeština 04/10/2013  
Remsima : EPAR - Summary for the public DA = dansk 04/10/2013  
Remsima : EPAR - Summary for the public DE = Deutsch 04/10/2013  
Remsima : EPAR - Summary for the public ET = eesti keel 04/10/2013  
Remsima : EPAR - Summary for the public EL = elliniká 04/10/2013  
Remsima : EPAR - Summary for the public EN = English 04/10/2013  
Remsima : EPAR - Summary for the public FR = français 04/10/2013  
Remsima : EPAR - Summary for the public IT = italiano 04/10/2013  
Remsima : EPAR - Summary for the public LV = latviešu valoda 04/10/2013  
Remsima : EPAR - Summary for the public LT = lietuvių kalba 04/10/2013  
Remsima : EPAR - Summary for the public HU = magyar 04/10/2013  
Remsima : EPAR - Summary for the public MT = Malti 04/10/2013  
Remsima : EPAR - Summary for the public NL = Nederlands 04/10/2013  
Remsima : EPAR - Summary for the public PL = polski 04/10/2013  
Remsima : EPAR - Summary for the public PT = português 04/10/2013  
Remsima : EPAR - Summary for the public RO = română 04/10/2013  
Remsima : EPAR - Summary for the public SK = slovenčina 04/10/2013  
Remsima : EPAR - Summary for the public SL = slovenščina 04/10/2013  
Remsima : EPAR - Summary for the public FI = suomi 04/10/2013  
Remsima : EPAR - Summary for the public SV = svenska 04/10/2013  
Remsima : EPAR - Summary for the public HR = Hrvatski 04/10/2013  

This EPAR was last updated on 31/03/2016 .

Authorisation details

Product details

Product details for Remsima
NameRemsima
Agency product numberEMEA/H/C/002576
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 Remsima
Marketing-authorisation holder

Celltrion Healthcare Hungary Kft.

Revision7
Date of issue of marketing authorisation valid throughout the European Union10/09/2013

Contact address:

Celltrion Healthcare Hungary Kft.
1023 Budapest, Regus Óbuda Gate
Árpád Fejedelem útja 26-28
Hungary

Product information

Product information

28/01/2016  Remsima -EMEA/H/C/002576 -IB/0033/G

Name Language First published Last updated
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016
Remsima : EPAR - Product Information HR = Hrvatski 04/10/2013 31/03/2016

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
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014
Remsima : EPAR - All Authorised presentations HR = Hrvatski 04/10/2013 25/09/2014

Pharmacotherapeutic group

Immunosuppressants, tumour-necrosis-factor-alpha (TNF╬▒) inhibitors

Therapeutic indication

Rheumatoid arthritis

Remsima, 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;
  • adult 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.

Adult Crohn’s disease

Remsima is indicated for:

  • treatment 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;
  • treatment 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

Remsima is indicated for treatment of severe, active Crohn’s disease in  children and adolescents aged six 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

Remsima 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

Remsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six 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

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

Psoriatic arthritis

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

Remsima 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.

Psoriasis

Remsima 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).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Remsima : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 27/01/2014 31/03/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Remsima : EPAR - Public assessment report HR = Hrvatski 04/10/2013  
CHMP summary of positive opinion for Remsima HR = Hrvatski 28/06/2013  

Authorised

This medicine is approved for use in the European Union

More information on Remsima