European regulators have this week approved Celltrion Healthcare’s Remsima SC for patients with rheumatoid arthritis (RA).
Remsima SC (CT-P13 SC, biosimilar infliximab) is the world’s first subcutaneous formulation of infliximab.
It is now 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).
Celltrion has also submitted a further variation to the marketing authorisation of Remsima SC to extend the indication to inflammatory bowel disease and the approval decision is expected in mid-2020.
The company said it expects to launch Remsima SC across Europe in the first quarter of 2020.