[THE INVESTOR] Celltrion announced on Nov. 17 that its antibody biosimilar Truxima has been approved by the Ministry of Food and Drug Safety for sale in South Korea.
Its reference drug is Roche’s Rituxan, a blockbuster drug with sales of 8 trillion won (US$6.83 billion) worldwide in 2015.
Identical to the original drug, Truxima treats lymphoma, chronic lymphocytic leukemia, rheumatic arthritis, Wegener’s granulomatosis, and microscopic polyangiitis.
Truxima is awaiting approval from European Medicines Agency, having filed an application in October, and will seek permission from the US Food and Drug Administration in the first half of 2017.
By Hwang You-mee (glamazon@heraldcorp.com)