Celltrion to begin China studies of Remsima

Celltrion Inc. (KOSDAQ:068270) has received clearance from China FDA to begin clinical trials of Remsima biosimilar infliximab, spokesperson Gunn Lee told BioCentury. Lee said Celltrion will become the first non-Chinese company to begin clinical studies of a biosimilar mAb in China.

Lee declined to say when the first study will begin, but noted that Celltrion submitted an IND to CFDA for Remsima in January 2014. The mAb against tumor necrosis factor (TNF) alpha is a biosimilar of Remicade from Johnson & Johnson (NYSE:JNJ), which is approved to treat autoimmune diseases including rheumatoid arthritis, psoriasis and Crohn's disease...