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Following the EU approval of Remsima IV in Nov’25, Celltrion launched Remsima IV, a biosimilar version of Remicade (Infliximab), across Europe
Celltrion has filed and secured patents for the Remsima liquid formulation across most EU countries, including key markets such as the UK, Germany, and France
The Remsima liquid formulation adds to existing IV (100 mg lyophilized) and SC options, aligning with clinical demand in Europe…
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 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…
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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,…

