China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Roche’s MabThera (rituximab), which is used for the treatment of follicular lymphoma (FL), CD20 positive diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
Phase III Study and Approval Basis
The approval is based on a multi-center, randomized, double-blind, parallel-controlled Phase III study that assessed the efficacy and safety of TQB2303 combined with the CHOP regime compared with MabThera combined with CHOP in naïve CD20+ DLBCL patients. The study demonstrated that Chia Tai Tianqing’s biosimilar was highly similar to the originator, with less polymer impurities and low molecular impurities, and more stability after production process optimization.
MabThera’s Market History and Chia Tai Tianqing’s Contribution
The originator, a monoclonal antibody (mAb) targeting CD20, was approved to treat B-cell non-Hodgkin’s lymphoma (NHLs) in the US in 1997 and entered the Chinese market in 2000. It was included in the National Reimbursement Drug List (NRDL) in 2017, with normal NRDL listing since 2019. HanLiKang was the first biosimilar in China, approved to treat non-Hodgkin’s lymphoma in 2019, followed by Innovent Bio’s Halpryza, which received market approval in 2020. Chia Tai Tianqing’s product is the third biosimilar to enter the market, offering an additional treatment option for patients with these conditions.-Fineline Info & Tech
