Canada approves Celltrion's subcutaneous injection for rheumatoid arthritis indication

 
SEOUL -- Celltrion's Remsima SC, the subcutaneous injection of Remsima, a copy of Janssen Biotech's Remicade treating rheumatoid arthritis and Crohn's disease, has secured approval from Canada's state health watchdog. Celltrion saw the green light as a bridgehead for its entry into the United States. Remsima SC can be injected into the fat layer beneath the skin at home.

Celltrion, a leading biosimilar manufacturer in South Korea, said on February 1 that Health Canada has approved Remsima SC's sales for rheumatoid arthritis indication. The company would apply for permission for inflammatory bowel disease indication later.

Infliximab is the basic ingredient of Remsima. In August 2020, Celltrion signed a joint development agreement with Intract Pharma, a British bio company, to develop oral infliximab in the form of pills. The target of Remsima SC is patients who are forced to move on to expensive secondary treatments due to resistance.

Celltrion has said that Remsima SC would increase its global presence rapidly because medical staff's preference for infliximab prescription is high in the field of inflammatory bowel disease. With Remsima SC, Celltrion has adopted an aggressive strategy to secure profitability and price penetration in competition with other subcutaneous-type products such as Adalimumab sold under the brand name of Humira, which is on the World Health Organization's list of essential medicines.