Celltrion, Inc. has achieved a significant milestone with the European Commission's approval of Remsima™ IV liquid formulation, marking the world's first liquid formulation of intravenous infliximab. The approval covers all previously approved indications for the powder formulation, including rheumatoid arthritis, adult and pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Regulatory Foundation and Comparability
The European Commission's approval is based on comprehensive chemistry, manufacturing, and controls data that established comparability between the lyophilized powder formulation and the new liquid formulation. The stability of the liquid formulation after reconstitution and dilution has been demonstrated to be comparable to that of the powder formulation, ensuring maintained efficacy and safety profiles.
Operational Efficiency and Cost Benefits
A multinational qualitative study conducted by Celltrion across seven European countries evaluated the operational benefits and cost savings of the liquid formulation compared to the powder version. The study involved semi-structured interviews with 21 hospital pharmacists and nurses involved in IV infliximab preparation.
The findings revealed substantial operational improvements: the liquid formulation reduces mean preparation time by approximately 51% while cutting preparation-related costs by 20%. These efficiency gains free up healthcare professionals' resources, enabling greater focus on patient care while reducing contamination risks.
Economic Impact and Storage Advantages
Simulation modeling based on the study data projects that adoption of Remsima™ IV liquid formulation could deliver up to €2.6 million in annual cost savings across the seven countries studied. These economic benefits stem from reduced preparation time, decreased consumable use, and lower labor costs associated with drug reconstitution and handling.
The liquid formulation's compact vial design offers additional logistical advantages, reducing storage space requirements by 50-70%. This supports hospital logistics while contributing to environmental sustainability by reducing waste and energy consumption associated with drug storage and preparation.
Clinical Perspective
"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."
Product Specifications and Availability
The Remsima™ IV liquid formulation is available in 100 mg vials and a newly introduced 350 mg presentation. The formulation eliminates the need for reconstitution, streamlining infusion preparation and reducing healthcare professionals' workload while supporting hospital operational efficiency.
Remsima™ IV, developed and manufactured by Celltrion, was the world's first monoclonal antibody biosimilar of reference infliximab. Originally approved in September 2013 and launched in major EU countries in early 2015, it is indicated for the treatment of eight autoimmune diseases. The company also offers subcutaneous infliximab (Remsima™ SC) with EU marketing authorization for treating patients with Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis in adult patients.
