Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic leukemia (CLL).
The originator drug, rituximab, a monoclonal antibody (mAb) that targets CD20, was first approved in the United States for the treatment of B-cell non-Hodgkin’s lymphoma (NHLs) in 1997 and subsequently gained marketing approval in China in 2000. The drug was included in the National Reimbursement Drug List (NRDL) in 2017 and has been regularly listed since 2019. Prior to this approval, Henlius, Innovent Bio, and Chia Tai Tianqing had secured approvals for their respective biosimilar versions in China in 2019, 2020, and 2023.- Flcube.com
