Celltrion Gets CHMP Positive Opinion for Rheumatoid Arthritis Treatment

• CT-P13 subcutaneous (SC) (biosimilar infliximab) recommended by CHMP for European Union (EU) marketing authorisation to treat rheumatoid arthritis (RA)
• CHMP positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version of CT-P13 in people with active RA
• Novel formulation provides an alternative administration option for physicians and their patients
• CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the EU

https://www.biospace.com/article/releases/celltrion-healthcare-receives-chmp-positive-opinion-for-novel-subcutaneous-formulation-of-ct-p13-biosimilar-infliximab-for-the-treatment-of-people-with-rheumatoid-arthritis/