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Celltrion receives Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of Rheumatoid Arhritis

Radius Health Creative, published February 12, 2021

TORONTO, Feb. 1, 2021 /CNW Telbec/ - Celltrion Healthcare Canada Limited announced today that Health Canada has granted a notice of compliance (NOC) for Remsima™ SC (CT-P13 SC) in Canada for the treatment of adult patients with rheumatoid arthritis (RA).

Rheumatoid arthritis is the most common chronic inflammatory joint disease and approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.1

Remsima™ SC is approved in Canada for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. Remsima™ SC should be used as maintenance therapy after the completion of an induction period with intravenous infliximab.2 The Health Canada NOC issued for Remsima™ SC is based on clinical evidence that showed the clinical response to Remsima™ subcutaneous (SC) formulation was comparable to CT-P13 IV up to 1 year. It was also shown that switching people with RA from the IV formulation to RemsimaTM SC at Week 30 was comparable to maintaining RemsimaTM SC up to Week 54 (up to Week 64 for safety profile).2,3

"Remsima™ SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. Remsima™ SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "The approval of Remsima™ SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."

With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima™ SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment.

As part of Celltrion's strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Canada to manage sales and marketing activities for Remsima™ SC.

"We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians 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.

Celltrion has applied for patent protection, until 2038, for Remsima™ SC in approximately 100 countries throughout North America, Europe and Asia.