The University of Oxford announces Celltrion’s infliximab biosimilar CT-P13 (Inflectra®, Remsima®) would be one of the products trialled in the CATALYST Study. This study is examining possible treatments for patients with COVID-19. It is hoped that the CT-P13...
Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.
Celltrion releases phase III results for switching studies comparing Biosimilar infliximab CT-P13 (marketed by Celltrion as Remsima® and by Pfizer as Inflectra®) and Remicade®, and phase I (open label) studies for sub-cutaneous infliximab.
FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.
Commercial (at risk) launch by Pfizer/Celltrion of Inflectra® (infliximab-dyyb).