According to industry sources on Aug. 2, the company has applied for US Food and Drug Administration’s approval to initiate phase 1 of clinical trials for SAIT101 in June.
|A Samsung BioLogics plant in Songdo, Incheon|
SAIT101 is a biosimilar version of rituximab, more commonly known as Roche’s Rituxan, used to treat non-Hodgkin’s lymphoma and autoimmune diseases. Also known as MabThera in South Korea and Europe, it is among the top five biological drugs sold worldwide, reaching US$7.3 billion in annual sales last year. Rituxan’s patent in US expires in 2018.
“Samsung’s bio businesses have two axis, CMO under BioLogics and biosimilar development under Bioepis, but with this it is strengthening the development sector,” an industry source said adding that “it can be understood as a step to expanding itself in the bio industry.”
By Hwang You-mee (email@example.com)