A comprehensive Cochrane review has found that biosimilar monoclonal antibodies demonstrate similar efficacy and safety profiles compared to their originator counterparts in the treatment of various cancers. The analysis, encompassing 55 studies with over 22,000 adult participants, provides robust evidence supporting the use of biosimilars in oncology.
The review focused on three biosimilar monoclonal antibodies: bevacizumab, rituximab, and trastuzumab, each targeting different cancers. The studies included patients with colorectal cancer, lung cancer, non-Hodgkin's lymphoma, and breast cancer. Researchers assessed key outcomes such as progression-free survival, overall survival, objective response rate, and the incidence of serious adverse events.
Bevacizumab Biosimilars in Lung and Colorectal Cancer
For bevacizumab biosimilars used in the treatment of lung and colorectal cancer, the review indicated that progression-free survival was similar to that of the originator bevacizumab. Specifically, at 12 months, progression occurred in 380 per 1000 participants in both the biosimilar and originator groups (HR 1.00, 95% CI 0.91 to 1.09; 5 studies, 2660 participants; moderate-certainty evidence). Overall survival rates were also comparable, with 592 deaths per 1000 in the biosimilar group versus 610 per 1000 in the originator group (HR 1.06, 95% CI 0.94 to 1.19; 5 studies, 2783 participants; moderate-certainty evidence).
The risk of serious adverse events was also similar between the bevacizumab biosimilar and originator, with 303 events per 1000 participants in the biosimilar group compared to 309 per 1000 in the originator group (RR 0.98, 95% CI 0.93 to 1.03; 23 studies, 10,619 participants; moderate-certainty evidence).
Rituximab Biosimilars in Non-Hodgkin's Lymphoma
In patients with non-Hodgkin's lymphoma, rituximab biosimilars showed similar progression-free survival compared to the originator rituximab (7 studies, 2456 participants; moderate-certainty evidence). The risk of serious adverse events was also comparable, with 210 events per 1000 participants in the biosimilar group versus 204 per 1000 in the originator group (RR 1.03, 95% CI 0.94 to 1.14; 15 studies, 4197 participants; moderate-certainty evidence).
Mortality rates were similar between the two groups, with 52 deaths per 1000 participants in the biosimilar group versus 53 per 1000 in the originator group (RR 0.97, 95% CI 0.70 to 1.35; 8 studies, 2557 participants; high-certainty evidence).
Trastuzumab Biosimilars in Breast Cancer
For breast cancer treatment, trastuzumab biosimilars demonstrated similar progression-free survival compared to the originator trastuzumab (4 studies, 2221 participants; moderate-certainty evidence). The risk of serious adverse events was also similar, with 129 events per 1000 participants in both groups (RR 1.00, 95% CI 0.85 to 1.17; 13 studies, 6183 participants; moderate-certainty evidence).
Objective response rates were slightly higher in the biosimilar group, with 801 responses per 1000 participants compared to 777 per 1000 in the originator group (RR 1.03, 95% CI 1.01 to 1.05; 13 studies, 5509 participants; moderate-certainty evidence).
The Cochrane review provides compelling evidence that biosimilar monoclonal antibodies offer comparable efficacy and safety to their originator counterparts in treating various cancers. These findings support the continued use and adoption of biosimilars in oncology practice, potentially offering cost-effective alternatives without compromising patient outcomes.
