European Commission Grants Approval of Remsima™ IV Liquid Formulation, World’s First Liquid Formulation of IV Infliximab
Remsima™ IV (intravenous) liquid formulation, the world’s first liquid formulation of IV infliximab has been approved by the European Commission (EC) for all previously approved indications for Remsima™ IV powder formulation1The approval is based on the comparability data between infliximab powder formulation and the liquid formulation2The new liquid formulation of infliximab, available in 100 mg and a newly introduced 350 mg presentation, eliminates the need for reconstitution and cuts drug preparation time by 51%, lowering preparation costs by 20%1,3Projected annual cost savings across seven European countries could reach up to €2.6 million, alongside significant improvements to workflow efficiency3
Celltrion, Inc. today 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.3
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).1
The comparability between lyophilized powder formulation and the liquid formulation of IV infliximab 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 infliximab.3
“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.”
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.3
Furthermore, simulation modeling based on this data projects that the adoption of Remsima™ IV liquid formulation could deliver up to €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.3
Notes to Editors:
About Remsima™(biosimilar infliximab)1
Remsima™ IV is developed and manufactured by Celltrion and was the world's first monoclonal antibody biosimilar of reference infliximab. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). It was approved in September 2013 and launched in major EU countries in early 2015.
Subcutaneous infliximab (Remsima™ SC) has received EU marketing authorization for the treatment of patients with CD, UC, rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO) in adult patients.
About Celltrion, Inc.
Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology.
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Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.
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References
1 European Medicines Agency. Remsima - Summary of Product Characteristics (SmPC). [Accessed Oct 2025]
2 Celltrion Data on File. CT-P13 Common Technical Document Module 3. Incheon, South Korea: Celltrion Regulatory Affairs; 2025 [cited 2025 May 23]
3 Nam K, Kwon TS, Di Biasio F, et al. Perceived benefits and cost savings of liquid formulation of intravenous infliximab: perspectives of seven European countries. Expert Opin Biol Ther. 2025;25(9):1017-1024. [Accessed Oct 2025]
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