Celltrion Gains Canadian Nod for Subcutaneous Infliximab

Celltrion Healthcare has received Canadian authorization to market a subcutaneous formulation of the infliximab biosimilar Remsima (Remsima SC; CT-P13), which was indicated for the treatment of rheumatoid arthritis (RA).

The company noted that 374,000 Canadians over the age of 16 have RA, the most common form of chronic inflammatory joint disease. Some Canadian provinces and territories are aggressively switching patients to biosimilars or contemplating doing so to improve savings over more-costly reference products.

Remsima SC was approved for use in combination with methotrexate to ease symptoms of moderate-to-severe RA and inhibit progression of structural damage and improve physical function in adult patients.

Subcutaneous vs Intravenous

Celltrion said Canadian regulators issued the “notice of compliance” allowing marketing to commence after weighing evidence demonstrating that the clinical response to Remsima SC was comparable to CT-P13 intravenous up to 1 year. Switching studies also demonstrated both products were comparable.

“Remsima SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure,” said Edward Keystone, professor of medicine, University of Toronto, Canada. “The approval of Remsima SC in Canada provides patients the opportunity to (self) administer the treatment at home, giving physicians and patients more control over their treatment.”

Remsima SC was authorized for the treatment of RA in the European Union in late 2019. At that time, the product was the first subcutaneous infliximab product to achieve regulatory approval anywhere. In July 2027, the product received EU approval for the treatment of adults with ankylosing spondylitis, Crohn disease, ulcerative colitis, psoriatic arthritis, and psoriasis.

Celltrion said sales and marketing of the product in Canada would be handled via the establishment of a Celltrion entity based in Canada. “We are proud that Remsima SC will be the first product to enter the Canadian market under our new direct sales marketing strategy. We plan to strengthen our presence in Canada and support the company’s growth,” said Jovan Antunovic, senior vice president and commercial director at Celltrion Healthcare Canada.

The company added that it “has applied for patent protection, until 2038, for Remsima SC in approximately 100 countries throughout North America, Europe and Asia.”