Celltrion 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 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.

Semi-structured interviews were conducted with 21 hospital pharmacists and nurses involved in IV infliximab preparation.

The comparability between the lyophilized powder formulation and the liquid formulation of IV infliximab has been established through comprehensive chemistry, manufacturing, and controls data. The stability of the liquid formulation of IV infliximab after reconstitution and dilution is comparable to that of the powder formulation of IV infliximab.

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’ resources, 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.

“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 optimize resources while maintaining efficacy and safety.”