Celltrion said the world's first Infliximab subcutaneous injection-type autoimmune disease treatment, "Remsima SC," has obtained approval for sale from the Health Canada on Jan. 28 (local time).
Remsima SC is a bio-medicine developed by changing its formulation from conventional intravenous injection (IV) to subcutaneous injection (SC), which greatly improves the convenience of treatment as patients can inject directly from where they want without visiting a hospital.
The approval of Remsima SC Canada was made for Rheumatoid Arthritis (RA) indication, and Celltrion plans to apply for permission for inflammatory bowel disease (IBD) indication later.
Canada's autoimmune disease treatment (TNF-α inhibitor) market is estimated to be about 2 trillion won as of 2019, and 374,000 adults aged 16 or older in Canada alone are reportedly suffering from rheumatoid arthritis.
"Remsima SC is similar in efficacy and safety to conventional IV formulations, which can improve treatment options for the use of Infliximab," said Edward Keystone, a professor at Mount Sinai Hospital in Toronto, Canada. "Remsima SC approval will provide patients with both home treatment opportunities and convenience for treatment."
An official from Celltrion said, "We expect the approval of Remsima SC Canada to be a bridgehead for entering the U.S. and other North American markets in the future."
Meanwhile, Celltrion Healthcare, which is in charge of overseas distribution and marketing of Celltrion's biopharmaceuticals, plans to establish a corporation in Canada and directly sell Remsima SC through its own direct sales network.
