Inflectra

Withdrawn

This medicine's authorisation has been withdrawn

infliximab

Overview

On 21 May 2026, the European Commission withdrew the marketing authorisation for Inflectra (infliximab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pfizer Europe MA EEIG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Inflectra was granted marketing authorisation in the EU on 10 September 2013 for the treatment of rheumatoid arthritis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2018. The product had not been marketed in the EU since March 2025.

Inflectra was a duplicate application to Remsima, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Remsima.

Inflectra : EPAR - Summary for the public

Inflectra : EPAR - Risk management plan

Product information

Inflectra : EPAR - Product Information

Inflectra : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Inflectra
• 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

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis

Inflectra, 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

Inflectra 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

Inflectra 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

Inflectra 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

Inflectra 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

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

Psoriatic arthritis

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

Inflectra 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

Inflectra 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).

Authorisation details

• EMA product number:
  EMEA/H/C/002778
• Biosimilar:

  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.

• Marketing authorisation holder:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Opinion adopted:
  27/06/2013
• Marketing authorisation issued:
  10/09/2013
• Withdrawal of marketing authorisation:
  21/05/2026
• Revision:
  35

Assessment history

Changes since initial authorisation of medicine

Inflectra : EPAR - Procedural steps taken and scientific information after authorisation

Inflectra : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Inflectra : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/589422/2013

CHMP summary of positive opinion for Inflectra

Adopted Reference Number: EMA/CHMP/364710/2013