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Celltrion Begins US Phase III For Infliximab SC, Aims For 2022 Launch

 
• By Jung Won Shin

Celltrion has begun a Phase III study with a subcutaneous version of its infliximab biosimilar in the US, after the FDA allowed it to skip Phase I and II trials based on approval data in Europe, enabling a lower development time and cost.

Celltrion researcher
Celltrion Takes New Drug Approval Pathway For Remsima SC • Source: Celltrion Inc.

Celltrion Inc. has begun to recruit patients for a US Phase III trial with a subcutaneous version of its infliximab biosimilar Remsima (CT-P13 SC) for inflammatory bowel disease, after it agreed with the FDA earlier this year to skip Phase I and II trials based on a vast amount of European approval data.

Celltrion told Scrip that it had taken a biosimilar (line extension) pathway in Europe, while in the US it has opted for a new drug approval pathway

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