Summary
Despite clinical guidelines, up to 28% of patients with ERBB2-overexpressing breast cancer do not receive ERBB2-targeted therapy due to the high cost, especially in low and middle-income countries. Furthermore, Black and Latinx patients are less likely to receive treatment due to financial toxicity and structural barriers to cancer care.
By introducing oncology biosimilars into the treatment landscape, cost savings can be achieved, and more patients can access treatment, particularly those who cannot afford optimal therapy. However, it is crucial to study the safety and efficacy of biosimilars in a population representative of the patients who would most benefit from this expanded access.
In this editorial, Flatiron researchers commented on a recent study of a phase 3 randomized trial that compared the cardiac safety and survival of SB3, a biosimilar for trastuzumab, with its originator product, trastuzumab, for ERBB2-overexpressing breast cancer to highlight opportunities for real-world evidence to address health equity gaps in the generalizability and transportability of clinical trial data and biosimilar studies.
Why this matters
Biosimilars can impact health equity, but their potential depends on how they are studied and adopted. Excluding marginalized populations from clinical trials may exacerbate existing health inequities, and unequal uptake across racial and ethnic groups can contribute to disparities in healthcare. To ensure accessibility and reduce inequities, data quality is essential. Without diverse representation in biomedical research, the evidence used for drug approvals fails to capture the full range of experiences and perpetuates inequities.