Therapy Areas: Autoimmune
Celltrion Healthcare clears European Commission approval for Remsima SC to treat rheumatoid arthritis
26 November 2019 -

Medication company Celltrion Healthcare reported on Monday the receipt of approval from the European Commission for Remsima SC ((CT-P13 SC, biosimilar infliximab) for the treatment of patients with rheumatoid arthritis in combination with methotrexate (MTX).

The company said Remsima SC, which is the world's first subcutaneous formulation of infliximab, is approved in the EU for treating rheumatoid arthritis in combination with methotrexate (MTX), when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX, has been inadequate as well as in adult patients with severe, active and progressive disease not previously treated.

This EU approval is based on clinical evidence from the company's 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.

Remsima SC's novel formulation provides an alternative administration option for European physicians and their patients. CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications, stated the company.

Additionally, the company has applied for patent protection until 2038 for Remsima SC in 100 countries in the US, Europe and Asia.