Posted by Michael Wonder on 26 Nov 2019
Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
25 November 2019 - European Union marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous version of CT-P13 in people with active rheumatoid arthritis.
Celltrion Healthcare today announced that the European Commission has approved Remsima SC (CT-P13 SC, biosimilar infliximab) for patients with rheumatoid arthritis (RA). Remsima SC is the world’s first subcutaneous formulation of infliximab.
Remsima SC is approved in the European Union for the treatment of people with rheumatoid arthritis in combination with methotrexate (MTX), in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including MTX, has been inadequate; and in adult patients with severe, active and progressive disease not previously treated with MTX or other DMARDs.
