Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)

Shots: The EC has approved Remsima IV (100mg and 350mg vials), a liquid formulation, a biosimilar version of Remicade The approval is supported by data showing the liquid and powder infliximab formulations are comparable in CMC characteristics and stability after reconstitution and dilution The Remsima IV liquid formulation is EU-approved for all existing IV infliximab indications, including RA, adult and pediatric CD and UC,…

ByDipanshu DixitNovember 18, 2025

Celltrion Launches Remdantry (Biosimilar, Remicade) Across Canada

Shots: Celltrion has launched Remdantry (formerly Inflectra) injection, a biosimilar to Remicade (infliximab), which will be launched on April 1, 2025, in Canada & received Health Canada NOC on March 7, 2025 Remdantry, consisting of a chimeric IgG1 mAb that binds to human TNFα, will share the same DIN as Inflectra. It was approved by…

ByDipanshu DixitMarch 28, 2025

Celltrion Presents the Long-Term Data for CT-P13 (biosimilar, infliximab) to Treat Inflammatory Bowel Disease (IBD) at ECCO 2024

Shots: The company presented 2yrs. results from the P-III (LIBERTY-CD) & (LIBERTY-UC) trial evaluating the superiority in safety & efficacy of CT-P13 (SC) vs Remicade in patients (n=180 & 237) with moderately to severely active CD & UC In the trials, 85.6% & 87% of patients completed the extension phase with clinical remission, clinical response,…

ByDipanshu DixitFebruary 21, 2024

Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)

Celltrion Launches Remdantry (Biosimilar, Remicade) Across Canada

Celltrion Presents the Long-Term Data for CT-P13 (biosimilar, infliximab) to Treat Inflammatory Bowel Disease (IBD) at ECCO 2024

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