Celltrion Healthcare Gets EU’s OK for Remsima SC to Treat Rheumatoid Arthritis

The European Commission granted marketing authorization to Celltrion for Remsima SC (CT-P13 SC, biosimilar infliximab) subcutaneous formulation for treatment of rheumatoid arthritis.

The approval was based on the results of a study which showed that switching patients from the intravenous formulation to the subcutaneous formulation of CT-P13 treatment at week 30 was comparable to maintaining CT-P13 SC up to 54 weeks of treatment.

CT-P13 was approved by the FDA in 2016 under the trade name Inflectra.