Celltrion refutes claims of study on Remsima® and Remicade®

The Centre for Biosimilars reports that Celltrion has refuted the claims of a July 2020 study which critiqued the methods used by Celltrion and the FDA to determine whether Remsima® (biosimilar infliximab) was equivalent to Remicade®. Among its critiques of the study, Celltrion has argued that the study does not reflect the FDA review procedure and the principles of the regulatory guidelines.