Celltrion’s Remsima IV approved by EC in liquid form
Esme Needham | November 27, 2025 | News story | Research and Development | Celltrion Inc, Immunology
Celltrion’s Remsima IV, the first-ever liquid formulation of infliximab for autoimmune diseases, has been approved by the European Commission (EC).
Infliximab is used to treat rheumatoid arthritis, adult and paediatric Crohn’s disease, ulcerative colitis (UC), paediatric UC, ankylosing spondylitis, psoriatic arthritis and psoriasis. It has previously existed only in powder form, but Remsima IV is a liquid formulation (both are administered intravenously). Remsima IV has been approved for all indications of infliximab, and clinical research has shown that its stability in liquid form is comparable to infliximab’s stability when diluted and reconstituted.
Prior to approval, Celltrion conducted a qualitative study across seven European countries. Its findings showed that Remsima IV’s liquid formulation and compact vial design cut average preparation time by around 51%, preparation-related costs by 20% and storage space requirements by 50-70%.
Simulation modelling based on this data suggests that use of Remsima IV could save up to 2.6m euros annually across the seven countries studied.
“Infliximab has long been a cornerstone in the management of immune-mediated inflammatory diseases, offering significant benefits to patients and healthcare systems,” said Daniele Napolitano, IBD nurse at CEMAD, Fondazione Policlinico Gemelli IRCCS, Rome, Italy. “The approval of the new liquid formulation is welcome news, as it is expected to enhance efficiency in infusion settings by eliminating the reconstitution step and reducing preparation time and contamination risk – allowing us to optimise resources while maintaining efficacy and safety.”
Celltrion is a biopharmaceutical company with an extensive biosimilars portfolio. It previously launched the world’s first monoclonal antibody biosimilar, which was the original, non-IV version of Remsima.
