CHMP recommends extending the indication for Remsima SC to include Crohns disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.- Celltrion Healthcare

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Remsima ((CT-P13 SC, biosimilar infliximab) from Celltrion Healthcare Hungary Kft. The CHMP agreed to extend the indication of the subcutaneous formulation of Remsima to include treatment of adult patients with Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis, in line with the adult indications of the IV formulation.

In November 2019 the EU approved Remsima SC 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 was 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).