Posted by Michael Wonder on 23 Sep 2019
Celltrion Healthcare receives CHMP positive opinion for novel subcutaneous formulation of CT-P13 (biosimilar infliximab) for the treatment of people with rheumatoid arthritis
23 September 2019 - CHMP positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 subcutaneous and the intravenous version of CT-P13 in people with active rheumatoid arthritis.
Celltrion Healthcare today announced that the CHMP of the EMA has adopted a positive opinion for CT-P13 SC for marketing authorisation in the European Union (EU) in people with rheumatoid arthritis. CT-P13 SC is the subcutaneous version of Remsima (biosimilar infliximab, CT-P13).
This recommendation will now be reviewed by the European Commission, which has the authority to approve medicines in the EU.
