European Commission approves Remsima SC to treat rheumatoid arthritis.- Celltrion

Celltrion Healthcare announced that the European Commission has approved Remsima SC (CT-P13 SC, biosimilar infliximab) for patients with RA. Remsima SC is the world�s first subcutaneous formulation of infliximab.

Remsima SC is approved in the EU 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.

The approval is based on clinical evidence including results from a study that showed switching people with RA from the intravenous (IV) formulation to the subcutaneous (SC) formulation of CT-P13 treatment at Week 30 was comparable to maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile). The study was presented at this year�s American College of Rheumatology Congress.

�The approval of Remsima SC in Europe gives patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment�, said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium. �Remsima SC� has been shown to have a stable potency, and patients with RA on Remsima SC� develop fewer anti-drug antibodies - which can improve the effectiveness of a treatment - compared with those on CT-P13 IV.�

With the availability of the novel formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima SC can be injected by patients themselves, which has the potential to significantly reduce hospital visits, as well as save time normally required for hospital-administered IV treatment.