South Korea-based biopharmaceutical company Celltrion Inc (KRX:068270) announced on Tuesday that the European Commission has granted marketing authorisation for Remsima IV liquid formulation, the world's first liquid version of intravenous infliximab.
The new formulation is available in 100 mg and 350 mg vials and is approved for all indications of the existing powder formulation, including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
The liquid formulation eliminates the need for reconstitution, reducing preparation time by 51% and cutting related costs by 20%. A multinational study across seven European countries found that the formulation improves workflow efficiency, decreases contamination risks, and reduces storage space requirements by 50-70%.
Comparability with the powder formulation was demonstrated through comprehensive chemistry, manufacturing, and controls data.
Simulation modelling projects that adoption could generate up to EUR2.6m in annual savings across the seven countries studied.
European Commission approves Celltrion's Remsima IV liquid formulation
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