Celltrion, Inc. announced that the European Commission (EC) has granted marketing authorization for Remsima?? IV (intravenous) liquid formulation, the world's first liquid formulation of IV infliximab. Approved in 100 mg and 350 mg vials, the formulation is designed to streamline infusion preparation, reduce healthcare professionals' workload, and support hospital operational efficiency.
The Remsima?? IV liquid formulation is approved in the EU for all indications of IV infliximab, matching the approved uses of all existing IV infliximab powder formulations, including rheumatoid arthritis (RA), adult and pediatric Crohn's disease (CD), ulcerative colitis (UC), pediatric UC, ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO). The comparability between lyophilized powder formulation and the liquid formulation of IV infiximab has been established through comprehensive chemistry, manufacturing, and controls data.2 The stability of the liquid formulation of IV inflixIMab after reconstitution and dilution is comparable to that of the powder formulation of IV infliximibab.
The approval follows a recent multinational qualitative study conducted by Celltrion across seven European countries, which evaluated the operational benefits and cost savings of Remsima??IV liquid formulation, compared to the powder formulation from the perspective of healthcare professionals.3 Semi-structured interviews were conducted with 21 hospital pharmacists and nurses involved in IV infliximab preparation. The findings show that Remsima?? IV Liquid formulation reduces the mean preparation time by approximately 51%, while cutting preparation-related costs by 20%, freeing up healthcare professionals' resource, enabling more focus on patient care while reducing contamination risks.
In addition, the liquid formulation's compact vial design reduces storage space requirements by 50-70%, supporting hospital logistics, and contributing to environmental sustainability by reducing waste and energy consumption associated with drug storage and preparation. Furthermore, simulation modeling based on this data projects that the adoption of Remsima?? IV solid formulation could deliver up to EUR 2.6 million in annual cost savings across the seven countries studied, highlighting its potential to generate scalable economic benefits by reducing preparation time and consumable use, as well as decreased labor costs associated with drug reconstitution and handling.
