Implications of the First Liquid IV Infliximab Biosimilar

The European Commission (EC) has granted marketing authorization for a liquid formulation of intravenous (IV) infliximab under the brand name Remsima IV by Celltrion (1). Remsima is a biosimilar referencing Johnson & Johson’s Remicade (infliximab) (2). The approval marks the world’s first liquid formulation of IV infliximab, according to a Nov. 18, 2025 Celltrion press release (1).

The EC’s approval covers all previously authorized indications for the existing Remsima IV powder formulation and applies to the treatment of rheumatoid arthritis, adult and pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. The liquid formulation will be available in 100 mg vials and a newly introduced 350 mg vial.

“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, inflammatory bowel disease nurse at the Center for Digestive System Diseases, Fondazione Policlinico Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy, in the press release (1).

How will the new formulation drive preparation efficiency?

The transition from a lyophilized powder to a ready-to-use liquid formulation carries significant impact for biopharmaceutical preparation and logistics, such as the elimination of the reconstitution step, which is mandatory for the powder form (3). This change is designed to reduce the workload for healthcare professionals, streamline the infusion preparation process, and improve overall hospital operational efficiency (4).

A multinational qualitative study conducted by Celltrion across seven European countries evaluated the practical benefits of this liquid formulation from the perspective of hospital pharmacists and nurses involved in its preparation. The study found that the IV infliximab liquid formulation demonstrated a reduction in mean preparation time by approximately 51% and a preparation-related cost reduction of 20% (4). According to Celltrion, these efficiencies free up healthcare professionals’ resources, enabling them to focus more significantly on patient care (1).

What does regulatory comparability mean for IV infliximab stability?

The regulatory pathway for the IV infliximab liquid formulation hinged on establishing comparability with the existing powder formulation, and the EC’s approval was grounded in comprehensive chemistry, manufacturing, and controls data (1). These data demonstrated that the stability of the liquid formulation, after dilution, is comparable to that of the established powder formulation (5).

The clinical importance of infliximab as a treatment for immune-mediated inflammatory diseases is well established, benefiting both patients and healthcare systems (6) (see Table). “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,” said Napolitano in the release (1).

Can changes in drug formulation optimize hospital resource management?

Beyond time savings, the shift to a liquid formulation offers scalable economic advantages and improved logistics for hospitals (4). Simulation modeling based on the preparation data in Celltrion’s study projects that the adoption of the liquid formulation could generate substantial economic benefits, such as €2.6 million (US$3.0 million) in annual cost savings across the seven countries studied—benefits attributed to decreased labor costs associated with drug reconstitution and handling, as well as reduced use of consumables and shorter preparation times(4).

Further contributing to logistical efficiency, compact vial design reduces required storage space by 50%–70%, a benefit that supports hospital logistics and may contribute to environmental sustainability through waste and energy consumption reductions that are linked to drug storage and preparation processes (4).

References

1. Celltrion. European Commission Grants Approval of Remsima IV Liquid Formulation, World’s First Liquid Formulation of IV Infliximab. Press Release. Nov. 18, 2025.
2. Celltrion. FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13, a Proposed Biosimilar Infliximab, for All Eligible Indications. Press Release. Feb. 10, 2016.
3. Joshi, S.; Jindal, P.; Gautam, S.; et al. Mini Review on the Lyophilization: A Basic Requirement for Formulation Development and Stability Modifier. Assay Drug Dev. Technol. 2025, 23 (4). DOI: 10.1089/adt.2024.122
4. Nam, K.; Kwon, T. S.; 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. DOI: 10.1080/14712598.2025.2544756
5. Celltrion Data on File. CT-P13 Common Technical Document Module 3. Incheon, South Korea: Celltrion Regulatory Affairs. 2025.
6. Cheng, H. Assessing the Efficacy of Infliximab in Promoting Vascular and Mucosal Healing in Immunoglobulin-Resistant Kawasaki Disease: A Meta-Analysis. BMC Pediatr. 2025, 25 (1), 147. DOI: 10.1186/s12887-025-05482-2
7. EMA. Inflectra Product Page. ema.europa.eu (accessed Nov. 18. 2025).
8. EMA. Remsima Product Page. ema.europa.eu (accessed Nov. 18. 2025).
9. EMA. Flixabi Product Page. ema.europa.eu (accessed Nov. 18. 2025).
10. EMA. Zessly Product Page. ema.europa.eu (accessed Nov. 18. 2025).