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Celltrion

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,…

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Celltrion

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,…

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