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...