Candidate from Innovent Biologics and Eli Lilly met primary endpoints in phase 3 study.
Rituximab was originally marketed by Roche under the brand name Rituxan/MabThera, which received marketing approvals for the treatment of adult patients with Low-grade or follicular CD20-positive non-Hodgkin's lymphoma as a single-agent therapy or in combination with other chemotherapy medicines. It is a recombinant human-mouse chimeric anti-CD20 monoclonal antibody that binds to the CD20 antigens on the surfaces of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC).
Celltrion was the first company to develop a biosimilar for Rituxan, which is marketed under the name Truxima in the U.S. (approval received from the US Food and Drug Administration in late 2018).
Eli Lilly and Innovent Biologics are developing their own biosimilar candidate to rituximab – IBI301. Recently, the companies reported that IBI301 met pre-defined primary endpoints in two randomized clinical trials comparing IBI301 to rituximab, including a study in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study in patients with CD20-positive B-cell lymphoma.
The pharmacokinetic study is a randomized, double-blinded, parallel, positive-controlled single-dose clinical trial in China with an enrollment of 181 patients with the primary objective of comparing the PK profiles of Rituxan and IBI301. The phase 3 study is a multi-center, randomized, double-blinded, parallel, positive-controlled trial in China with an enrollment of 420 patients designed to investigate the efficacy and safety of IBI301 and rituximab in the first-line treatment of patients with newly diagnosed DLBCL.