Remsima

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infliximab

Authorised
This medicine is authorised for use in the European Union.

Overview

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 immune-system diseases:

  • rheumatoid arthritis (a disease causing inflammation of the joints). Remsima is used with methotrexate (another 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 fistulas, 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 6 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.

Remsima is a ‘biosimilar’ medicine. This means that Remsima is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Remsima is Remicade.

This EPAR was last updated on 29/05/2020

Authorisation details

Product details
Name
Remsima
Agency product number
EMEA/H/C/002576
Active substance
infliximab
International non-proprietary name (INN) or common name
infliximab
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Spondylitis, Ankylosing
  • Colitis, Ulcerative
  • Psoriasis
  • Crohn Disease
  • Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AB02
BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Celltrion Healthcare Hungary Kft.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
10/09/2013
Contact address
1062 Budapest
Váci út 1-3. WestEnd Office Building B torony
Hungary

Product information

20/05/2020 Remsima - EMEA/H/C/002576 - N/0087

Contents

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Pharmacotherapeutic group

Immunosuppressants

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

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