Celltrion nabs EU approval of first subcutaneous infliximab biosimilar

South Korea’s Celltrion Healthcare (Kosdaq: 068270) 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, which is marketed as Remicade by Johnson & Johnson (NYSE: JNJ) subsidiary Janssen. Remsima SC will launch in major markets such as Germany, the UK and the Netherlands in the first quarter of 2020, estimated to be worth $4 billion. By the fourth quarter, the domination rate is expected to reach 89%, worth $7.9 billion, according to Celltrion’s projections.

Celltrion was the first drug developer to win approval for a biosimilar monoclonal antibody (MAb) from the European Medicines Agency (EMA) in 2013 and the US Food and Drug Administration (FDA) with its copy of Remicade in 2016, although several others have since been approved.