Celltrion said Thursday that it has received regulatory approval for Truxima (Original: Rituxan), a monoclonal antibody (mAb) biosimilar that treats certain autoimmune diseases and some types of cancer, from Health Canada.

Celltrion headquarters in Incheon

Truxima also treats illnesses such as non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CCL), rheumatoid arthritis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, and myasthenia gravis. The Canadian agency approved the medication for treating NHL, CLL and rheumatoid arthritis.

According to IQVIA, a market research company, Rituxan, the original drug of Truxima, posts annual sales of about 250 billion won ($219.5 million) in Canada. Celltrion Healthcare, which is in charge of overseas distribution and marketing of Celltrion products, plans a strategic launch of the product with close coordination with Teva Pharmaceutical, its North American distribution partner of the biosimilar.

The approval came after Celltrion acquired sales approval from the Food and Drugs Administration to sell the Truxima in the U.S. in November last year. With the approval in Canada, the company has completed preparations to become a “first mover” into the North American rituximab market, which is worth 5 trillion won.

The Canadian government has recently expressed a strong commitment to reducing healthcare spending by announcing policies to reduce medical costs and improve patient access to biopharmaceuticals. In light of such goals, the government has been promoting the prescription of biosimilars to new patients, while supporting the policy by simplifying the prescription process compared to the original drug.

“Celltrion has demonstrated the safety and efficacy of our antibody biosimilar products with clinical data and has accumulated medical trust in the global market,” a company official said. “The company will do its best to provide Canadian patients with high-quality cancer biosimilars at a reasonable price.”

corea022@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>