Celltrion applies for approval of Xolair biosimilar in Canada

South Korean biopharmaceutical company Celltrion Inc. announced on Wednesday that it has applied for CT-P39, a biosimilar of the treatment of asthma and urticaria Xolair from Health Canada.

Xolair is a monoclonal antibody biopharmaceutical developed by the US-based Genentech and Novartis in Switzerland. It is used as a treatment for allergic asthma, chronic idiopathic urticaria, and chronic rhinosinusitis with nasal polyps.

According to global pharmaceutical market research firm IQVIA, Xolair is a blockbuster drug that achieved global sales of $3.89 billion last year.

Celltrion has developed CT-P39 and completed regulatory submissions in South Korea and Europe earlier this year. The company has now applied for product approval with Health Canada.

The company anticipates market expansion in Canada as the country has actively encouraged biosimilar prescriptions since 2019.

“Canada’s pro-biosimilars stance is a great opportunity to diversify our biosimilar pipeline including autoimmune and allergic conditions and expand the overseas market,” a Celltrion source said.

Celltrion has commercialized a total of six biosimilars to date, including Xolair. The company aims to introduce 11 biosimilar products to the market by 2025 and 22 by 2030.

Write to Jeong Min Nam at peux@hankyung.com