Celltrion said Monday that Health Canada has given the go-ahead for Remsima SC, a Remicade biosimilar that treats rheumatoid arthritis.

Celltrion has received approval to market its biosimilar drug to treat rheumatoid arthritis, Remsima SC, in Canada. (Celltrion)
Celltrion has received approval to market its biosimilar drug to treat rheumatoid arthritis, Remsima SC, in Canada. (Celltrion)

With the approval, Celltrion Healthcare, responsible for the company's overseas distribution and marketing, plans to establish an offshoot in Canada and sell Remsima SC directly.

Celltrion also plans to expand indications for the biosimilar to treating inflammatory bowel disease too.

According to the company, the Canadian autoimmune disease treatment (TNF-α inhibitor) market was sized at about 2 trillion won ($1.7 billion) in 2019, with 374,000 adults over 16 who have rheumatoid arthritis.

"The company expects that this approval will become a bridgehead for entry into the North American market, including the U.S.," a company official said.

Remsima SC, the subcutaneous version of Remsima, is a biosimilar referencing Johnson & Johnson's autoimmune disease treatment Remicade. By changing the injection from the intravenous to subcutaneous type, Remsima SC became more convenient for patients, Celltrion added.

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