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Celltrion bags Canadian approval for Truxima

More affordable blood cancer treatment to arrive in Canada, exact launch date to be determined

Celltrion recently gained approval from the Canadian Health Ministry to begin sales of Truxima, a rituximab biosimilar used to treat blood cancer, the company announced Thursday.

“Celltrion will quickly enter the Canadian market so that patients there will enjoy a more affordable high-quality anticancer biosimilar,” said a Celltrion representative.

This is the first time Canada has approved a rituximab biosimilar.

Truxima (Celltrion)
Truxima (Celltrion)

Canada has made efforts of late to cut drug costs and improve patient accessibility to biosimilar products. Biosimilars are comparatively cost-effective drugs that are almost identical to biopharmaceuticals for which patents have expired.

The Canadian government encourages the use of biosimilars and has simplified the approval process based on demonstrated similarity between a biosimilar and the referenced biologic drug. The eased regulations took effect in April 2017.

Truxima’s launch schedule for Canada will be determined by Celltrion Healthcare, which manages Celltrion products’ overseas distribution and sales, after discussions with its North American distribution partner firm Teva Pharmaceutical.

Truxima can be used to treat non-Hodgkin lymphoma, a cancer that starts in white blood cells; chronic lymphocytic leukemia, a blood and bone marrow cancer; and rheumatoid arthritis, an autoimmune disorder that affects joints. The biosimilar references the Biogen-developed and Roche-sold blockbuster treatment Rituxan, which annually records approximately 250 billion won ($219 million) in sales in Canada.

Celltrion gained the green light to commercialize Truxima in the US in November 2018. Now that it is about to make its debut in Canada, the drugmaker has a foothold in the North American blood cancer treatment market, which is estimated to be worth 5 trillion won. Worldwide, the blood cancer treatment market is estimated to grow to $55.6 billion by 2024, according to a new report by Polaris Market Research.

Celltrion has sold autoimmune treatment biosimilar Remsima in Canada under the local name Inflectra since January 2015. Partner firm Pfizer manages Inflectra sales.

By Lim Jeong-yeo (