Home » Celltrion Healthcare Gets EU’s OK for Remsima SC to Treat Rheumatoid Arthritis
Celltrion Healthcare Gets EU’s OK for Remsima SC to Treat Rheumatoid Arthritis
December 9, 2019
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.
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