The global landscape of drug development of trastuzumab biosimilars

Background: Limited access to prevention, screening, timely diagnosis, affordable and effective treatment is the main driver of disparities in cancer care. The high costs represent a common barrier for the affordable access to biological agents. The only biological agent included in the World Health Organization list of essential medicines for the management of breast cancer is trastuzumab, and its biosimilars. Methods: We reviewed the pivotal trials for approved trastuzumab biosimilars and searched the proposed biosimilars under investigation in clinical trials, then mapped them against metrics of national epidemiology and health system capacity. Results: Thirteen clinical trials were extracted. Across 40 countries and 825 research facilities, more than three- fourth enrolling centers were located in low- and middle- income countries (n = 633) Correlation analysis suggested that the research and drug development of biosimilars was prioritized in settings where weaker health systems can result in poorer cancer- related outcomes and higher out of pocket expenses (range of r: -0,37; + 0.53; all p-values <0.05). Eleven countries had no biosimilars approved at the time of the analysis: in these countries, the drug development of biosimilars was more represented. Conclusion: The drug development of biosimilars occurs significantly in low- and middle- income countries. Our correlative findings must be interpreted cautiously, to understand if the biosimilar drug development is congruent with the national health priorities of cancer control. Health, societal and economic impacts on populations should be accounted, as relevant metrics for clinical trial implementations. Policy Summary: The implementation of cancer research should be developed under the national cancer control priorities, to ensure consistency across the evidence- informed relevant national policies, thus result in a population health impact. Biosimilars drug development can drive tangible population health benefits by accelerating the uptake of more sustainable health interventions and shaping more efficient regulatory environments.