Remsima - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

infliximab

Opinion

On 18 September 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Remsima. The marketing authorisation holder for this medicinal product is Celltrion Healthcare Hungary Kft.

The CHMP adopted a new pharmaceutical form and a new strength, concentrate for solution for infusion 40 mg/mL  (in two vial presentations, 100 mg in 2.5 mL and 350 mg in 8.75 mL). The new formulation is associated with the following new contraindication:

Patients with hereditary fructose intolerance (HFI). Prior to initiating treatment, HFI should be excluded on age-appropriate clinical grounds (see section 4.4).

For the full list of contraindications for each pharmaceutical form, please refer to the summary of products characteristics (SmPC).

Detailed recommendations for the use of this product will be described in the updated SmPC, which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

CHMP post-authorisation summary of positive opinion for Remsima (X-149)

Adopted Reference Number: EMA/314083/2025

Key facts

• Name of medicine:
  Remsima
• EMA 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 therapeutical chemical (ATC) code:
  L04AB02
• 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:
  Celltrion Healthcare Hungary Kft.
• Date of opinion:
  18/09/2025
• Статус:
  Positive