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Celltrion Plans EU Filing For Remsima SC As Phase III Completed

 
• By Jung Won Shin

Celltrion is preparing to make a filing in the second half for the regulatory approval in the EU of a subcutaneous version of its infliximab biosimilar Remsima, the first biosimilar with a changed formulation, in an effort to diversify its portfolio and boost the product's market competitiveness.

Celltrion Headquarters
Celltrion Plans EU Filing For SC Formulation Of Infliximab Biosimilar • Source: Celltrion Inc.

Celltrion Inc. is gearing up to file a marketing authorization with the European Medicines Agency for Remsima SC, a subcutaneous (SC) version of its autoimmune disease therapeutic antibody infliximab, a biosimilar version of Johnson & Johnson's Remicade, following the completion of a Phase III clinical trial.

Celltrion said it is set to complete the clinical analysis for the trial soon and to submit the approval application...

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