South Korea’s Celltrion Inc., received new drug submission (NDS) approval from Health Canada for Omlyclo, the biosimilar of allergic asthma and chronic idiopathic urticaria treatment Xolair, the company said on Monday.
With this approval, Celltrion can sell Omlyclo in Canada for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic Idiopathic urticaria.
Xolair is a monoclonal antibody biopharmaceutical developed by the US-based Genentech and Novartis in Switzerland.
Last year, Xolair reported global sales of around $3.5 billion. The Canadian market is estimated to be worth $138 million.
Write to Jeong Min Nam at peux@hankyung.com
Celltrion founder and Chairman Seo Jung-jin speaks at Korea Investment Week 2024, hosted by the Korea Economic Daily, on Sept. 11, 2024 South Korea’s leading biosimilar developer Celltrion Inc. will break ground on its first contract development and manufacturing organization (CDMO) plant
Remsima obtained FDA approval in 2016 Celltrion Inc.'s Remsima, the world’s first biosimilar monoclonal antibody, is on track to exceed 1 trillion won ($713 million) in sales this year to become the first Korean drug to do so. Remsima raked in 979.7 billion won in sales in the first