Rituximab Biosimilars Prove Effective in Large B-Cell Lymphoma

Abstracts from the European Hematology Association Congress 2022 confirmed comparable safety and effectiveness profiles between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.

Abstracts from the European Hematology Association (EHA) Congress 2022 assessed the safety and effectiveness of 2 rituximab biosimilars compared with the reference product (Rituxan) in patients with untreated large B-cell lymphoma.

Sandoz Rituximab Biosimilar Over 2 Years1

Sandoz’ rituximab biosimilar (Riximyo, Rixathon, SDZ-RTX) was approved in the European Union for the same indications as the reference product. The investigators conducted the REFLECT study, a real-world, multicenter, open-label, single-arm, non-interventional trial.

The study was also the first prospective, postapproval trial of Riximyo in combination with cyclophosphamide, doxorubicin, vincristine (Oncovin), and prednisone (R-CHOP) as a possible curative therapeutic regimen for CD-20–positive diffuse large B-cell lymphoma (DLBCL).

For inclusion, patients had to be 18 years or older with CD-20–positive DLBCL and treatment naïve. The patients received R-CHOP every 2 or 3 weeks for 6 to 8 cycles, and the investigators collected data during a 12-month treatment period and during the first 30 days after the last R-CHOP dose.

In total, 169 patients with DLBCL, of whom 52.1% were women and the mean (SD) age of the group was 67.3 (13.4) years, were included in the analysis. Overall, 110 patients achieved complete response and 50 experienced a partial response. The overall response rate was 94.7%.

Progression-free survival (PFS) at 1 year and 2 years was achieved by 84.9% and 78.5% of patients, respectively. At least 1 adverse event (AE) was reported by 143 (84.6%) patients, with the most common being anemia (24.3%), fatigue (20.7%), polyneuropathy (17.2%), and nausea (12.4%). Serious AEs were reported by 63 patients, 11 of whom were suspected to have AEs related to the treatment. In total, 8 deaths were recorded, of which 3 occurred during the treatment period.

A Danish Population Analysis of Rituximab Biosimilar2

In a population-based analysis from Denmark, investigators assessed the efficacy of R-CHOP therapy with a rituximab biosimilar vs the originator using a lymphoma registry between January 2015 and January 2022.

For inclusion, patients had to have DLBCL and be treated with CHOP or CHOP-like treatment. Data on the dates when patients were switched from Rituxan to a biosimilar were collected from pharmacies within treating hospitals, and the primary end point was PFS.

Overall, 2372 patients with a median age of 70 years were analyzed, 1049 of whom received the reference product and 1343 received the biosimilar. The 3-year PFS for the originator and biosimilar groups was 71.8% and 72.2%, respectively. The multivariable analysis revealed no significant differences in PFS or overall survival between the groups, producing hazard ratios of 0.94 (95% CI, 0.81-1.10) and 0.99 (95% CI, 0.83-1.17) in the originator and biosimilar groups, respectively.


  1. Hanes V, Pan J, Mytych D, Chow V. Prospective non-interventional study on the effectiveness and safety of Sandoz rituximab (SDZ-RTX) with chop for patients with previously untreated CD20-positive diffuse large B-cell lymphoma. Presented at: EHA2022; June 9-12, 2022; Vienna, Austria. Abstract P1171.
  2. Hanes V, Pan J, Mytych D, Chow V. Efficacy of rituximab and biosimilar rituximab in untreated diffuse large B-cell lymphoma, a Danish population based analysis. Presented at: EHA2022; June 9-12, 2022; Vienna, Austria. Abstract P1224.
Related Videos
Michael Kleinrock
Here are the top 5 biosimilar articles for the week of February 13th, 2023.
Michael Kleinrock
Nabil Saba
Paul Reider
Ryan Haumschild, PharmD, MS, MBA
Sonia T. Oskouei, PharmD, BCMAS, DPLA0
Eric Tichy, PharmD, MBA
Sonia T. Oskouei, PharmD, MS
Eric Tichy, PharmD, MBA
Related Content
© 2023 MJH Life Sciences

All rights reserved.